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1.
IRCT; 2021-10-11; TrialID: IRCT20210620051639N2
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20210620051639N2

ABSTRACT

Condition:

COVID-19.
U07.1 COVID-19, virus identified;U07.1

Intervention:

Intervention 1: Intervention group: receiving 80 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle). Intervention 2: Control group: the placebo group will receive an intramuscular injection (in the deltoid muscle) consisting of buffer and adjuvant only, on days 0, 21, and 35.

Primary outcome:

IgG antibody against Receptor Binding Domain (RBD) protein. Timepoint: in days 0, 35, 49, 125, 215 after injection of the first dose of vaccine. Method of measurement: based on ELISA method and seroconversion rate (proportion of individuals with at least twofold and fourfold increases) and Geometric Mean Titer (GMT).;Cellular immunity response against recombinant vaccine RBD protein. Timepoint: in days 0 and 49 after injection of the first dose. Method of measurement: determining Th1 or Th2 dominance based on levels of IL-4? IL-10? IL-12? ? INF? with ELISA measurement, and levels of CD3? CD4? CD8 with INF? based on flow cytometry measurement.;Measurement of neutralizing Antibody based on virus neutralizing test (VNT). Timepoint: in day 49 after injection of the first dose. Method of measurement: Based on the cell culture and inhibition of virus entry (Neutralizing titer).

Criteria:

Inclusion criteria: Healthy persons, 18-40 years old,
Without uncontrolled underlying disease

Exclusion criteria: History of Covid-19 disease in the past month, positive coronavirus PCR test, uncontrolled underlying disease, T Important surgical history, receiving corona vaccine

2.
IRCT; 2021-08-23; TrialID: IRCT20180201038585N11
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20180201038585N11

ABSTRACT

Condition:

Covid-19.
COVID-19, virus identified;U07.1

Intervention:

Intervention 1: Intervention group: At the beginning of the study, patients in the intervention group will receive 30-gram sachets of functional food (functional soup). Patients in the intervention group will be asked to consume a 30-gram packet of functional food (functional soup) daily in the morning for 1 week. In order to increase compliance, patients were asked on a daily basis. Intervention 2: Control group: Patients in the control group will receive 30-gram packages of regular food (barley soup) at the beginning of the study. Patients in the control group will be asked to consume a 30-gram packet of regular food (barley soup) daily in the morning for 1 week. In order to increase compliance, patients are asked on a daily basis.

Primary outcome:

The amount of inflammatory and anti-inflammatory cytokines (Il-1ß? Il-6? TNFa?IL-10? IL-4 ,IFN? ). Timepoint: At the start and after 1 week of study. Method of measurement: Through intravenous blood samples and commercial kits.

Criteria:

Inclusion criteria: The need for hospitalization with clinical signs in favor of coronavirus infection includes one or more of the following : The patient experiences a decrease in oxygen saturation of less than 93%
A drop in systolic blood pressure less than 100 or a drop in blood pressure of 30 mm Hg from the patient's previous normal systolic pressure
fever
Dry cough
the positive result of CRP index
Laboratory indexes included : CRP , ESR

Exclusion criteria: Patient dissatisfaction
Lack of proper conditions for oral feeding

3.
IRCT; 2021-06-25; TrialID: IRCT20210620051639N1
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20210620051639N1

ABSTRACT

Condition:

COVID-19.
COVID-19, virus identified;U07.1

Intervention:

Intervention 1: Intervention group: receiving 80 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle). Intervention 2: Intervention group: receiving 120 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle). Intervention 3: Control group: the placebo group will receive an intramuscular injection (in the deltoid muscle) consisting of buffer and adjuvant only, on days 0, 21, and 35.

Primary outcome:

Any immediate adverse reaction after inoculation. Timepoint: 30 min after injection. Method of measurement: close monitoring.;Any local adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any systemic adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any laboratory adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any serious adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any serious adverse event, medically attended adverse event, or adverse event of interest. Timepoint: 0-125 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.

Criteria:

Inclusion criteria: Age between 18 and 50 years old
Healthy in terms of past medical history, physical examination, and laboratory data-
Body mass index: 17-35 kg/m2
Willingness to participate in the study and complete follow-up
Ability to comprehend study methodology
Ability to comprehend and sign informed consent-
Provision of consent to access medical documents in case of contracting COVID-19
For women: negative pregnancy screening
Acceptance of contraception use from 21 days before randomization until six months after receiving the last vaccine dose
Acceptance of not receiving blood product or bone marrow from randomization until three months after receiving last vaccine dose

Exclusion criteria: Positive COVID-19 PCR test
Positive antibodies against SARS-CoV-2 (IgG, IgM)
History of infection with SARS-CoV-2 documented with RT-PCR test
Close contact with COVID-19 infected individual in the past 14 days
Isolation due to signs and symptoms that are suspicious of COVID-19
Fever (axillary temperature > 37° C), dry cough, fatigue, nasal congestion, rhinorrhea, sore throat, myalgia, diarrhea, dyspnea in the past 14 days
Laboratory abnormalities in biochemistry profile, blood, and urine (including urea, creatinine, fasting blood sugar, Na, K, aspartate transaminase, alanine transaminase, alkaline phosphatase, total bilirubin, hemoglobin, leukocyte count, neutrophil count, lymphocyte count, platelet count, urine protein, urine glucose, blood cells in urine)
History of severe allergic reactions or allergy to vaccine components (latex)
Experience to severe allergic or allergic reactions to components of the recombinant RBD protein vaccine (latex sensitivity)
Personal or family history of seizure, epilepsy, encephalopathy, psychiatric disorder
Congenital malformations
-History of neurologic diseases or seizure (except for febrile seizure at childhood)
Growth disorders
Genetic disorders
Malnutrition
Renal or liver abnormalities
Uncontrolled hypertension (>140/90 mmHg)
Heart failure with NYHA class =2
Recent exacerbations of cardiovascular disease include cardiovascular intervention, the addition of new cardiovascular drugs to control symptoms, or unstable angina.
Chronic obstructive lung disease with GOLD score =2-
Asthma
Diabetic complications
BMI > 35 kg/m2
History of malignancy in the past five years
Exacerbation of chronic diseases in the past 7 days
Immunodeficiency, lymphoma, leukemia, autoimmune diseases
Thyroid disease or history of thyroidectomy without proper control
Splenectomy or history of resection of solid organs
Coagulation abnormalities
Anti-tuberculosis treatment
Positive HBSAg
Positive HIV Ab
Positive HCV Ab
Receiving immunosuppressive therapy for 14 consecutive days in the past 3 months or need for such therapy in the following 6 months
Receiving any off-label or investigational therapy for COVID-19
Receiving flu vaccine in the past 14 days or other vaccines in the past 4 weeks
History of drug or alcohol abuse in the prior year
Receiving immunoglobulin or blood products in the prior 3 months
Receiving investigational drugs in the past 45 days
Planning to receive other vaccines in the next month
Severe psychiatric disorders interfering with participation in the trial
Women with positive beta-HCG, pregnancy, or during breastfeeding, or plan to become pregnant during the study
High risk occupation for COVID-19 exposure (health care workers) or with decision of investigators
First degree family members of the trial personnel
Any other reason that the investigators document making volunteers ineligible-

4.
IRCT; 2021-04-12; TrialID: IRCT20210325050769N1
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20210325050769N1

ABSTRACT

Condition:

COVID-19.
COVID-19, virus identified;U07.1

Intervention:

Intervention 1: Intervention group: The drug (including tea, honey and royal jelly for 5 days) is delivered to the hospital along with the list of codes of patients in the intervention group (to be presented to patients in the intervention group).The composition inside each CRSM-X7 tea bag includes 10 grams of marshmallow, 5 grams of Sweet violet, 5 grams of Wild mallow, 5 grams of Damask rose, 10 grams of Liquorice root. After identification and registration, they will be placed in special bags for use. Each bag of CRSM-X7 herbal tea is infused in a volume of 300 ml of boiling water for one day use. After the temperature of the drink is reduced (it reached the temperature of 40 ° C), 5 cc of lavender honey is added, dissolved in it and drunk. So that, three glasses (each glass is equivalent to 100 ml) will be drunk per day (half an hour before breakfast, one hour before lunch, one hour before bedtime) up to five days by the intervention group. The seventh element of this supplement is Royal Jelly, which is prepared in the proportion of 50 grams of Royal Jelly in one kilo gram of lavender honey and should be used by the people under study 4 meals a day, ie morning, noon, evening, night for 5 days (each Promise of 2.5 cc). Intervention 2: Control group: Control group: 92 people are in the control group, which includes other patients and hospitalized in the same treatment center who receive a standard treatment regimen similar to the intervention group.

Primary outcome:

Hospitalization time. Timepoint: Before starting the study and after 5 days of using herbal supplements. Method of measurement: A researcher-made questionnaire whose validity and reliability have been assessed.

Criteria:

Inclusion criteria: Diagnosis of COVID-19
Age 18-65
Having informed and written consent to participate in the study

Exclusion criteria: Disagreement of the physician directly responsible for the patient
Pregnancy and breastfeeding
Allergies to the drug elements
Symptoms of gastrointestinal, liver or kidney disease
Incidence of drug interactions
Patient dissatisfaction to continue the project for any reason
Inability of the patient to receive oral medication
Hypertension
Having heart failure
Do not take anticoagulants (aspirin, Plavix, warfarin)

5.
IRCT; 2021-02-13; TrialID: IRCT20210205050247N1
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20210205050247N1

ABSTRACT

Condition:

olfactory loss.
Other disturbances of smell and taste;R43.8

Intervention:

Intervention 1: Intervention group: This group will be treated with respiratory physiotherapy or olfactory rehabilitation for 12 weeks. Intervention 2: Intervention group: The second group will be treated with vitamin A tablets (10,000 units per day) along with the olfactory rehabilitation method for 12 weeks. Intervention 3: Control group: The third group of patients will not receive any treatment intervention and these patients will be followed up for 12 weeks.

Primary outcome:

Smell Identification. Timepoint: The olfactory test is performed for 12 weeks, twice a day, each time inhaling each odor for 10 seconds. Method of measurement: Aromatic kit that includes 4 main scents (eucalyptus, lemon, rose and Dianthus).

Criteria:

Inclusion criteria: Age between 20 and 65
No underlying disease including: hypertension, hypo and hyperthyroidism, seizures, diabetes, asthma, Bell's palsy
Continuation of olfactory reduction for more than two weeks

Exclusion criteria: Patient dissatisfaction
Prolonged exposure to some chemicals agents (detergents)
History of head trauma
History of sinus surgery or septorhinoplasty, rhinoplasty, turbinectomy and radiation therapy
Having neurodegenerative disease (Alzheimer's, Parkinson, MS, epilepsy, seizures)
Having mental disorders (schizophrenia and depression)
Having neuropsychiatric disorders (autism, Asperger's, lack of concentration and hyperactivity)
History of repeated use of the following drugs:Metronidazole, benzocaine, clofibrate, amphotericin B, ampicillin, allopurinol, captopril, baclofen, codeine, carbamazepine and amphetamines.

6.
IRCT; 2021-01-12; TrialID: IRCT20200318046812N3
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20200318046812N3

ABSTRACT

Condition:

COVID-19.
COVID-19, virus identified;U07.1

Intervention:

Intervention 1: ''Intervention group:'' In this group, probiotics are given to the patients' families. Biomus supplement consists of 12 essential vitamins and minerals along with probiotics (a mixture of three native Iranian strains including Lactobacillus casei, L. rhamnosus and L. helveticus ). All these items are prepared in one capsule to strengthen the immune system and digestive system against viral and bacterial diseases.Three capsules of medicine/placebo are delivered daily to the participants after receiving informed consent and the eligibility of the cluster at the initial visit. In follow-up visits, after receiving the previous drug pack/placebo, the new treatment is sent to the patient's family using a courier. The amount of medicine/placebo delivered is enough until the next visit. Intervention 2: ''Control group'': Placebo is given to patients three times a day.

Primary outcome:

?S?everity of cough. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone followup.;?Severity of shortness of breath. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone followup.

Criteria:

Inclusion criteria: Confirmation of infection by PCR in a family member
Informed written consent
Living in Tehran
Number of family members between 2 and 5
Age between 18 to 63 years
No prognostic signs of Covid-19 disease two weeks before enrollment

Exclusion criteria: Not participating in another clinical trial in the last three months
Do not use other supplements (containing vitamins, minerals, and probiotics)
No documented history of Covid-19 infection in healthy family members
Pregnancy / breastfeeding
Drug sensitivity to the compounds in the intervention
Temporary residence or immigration and consecutive relocation from Tehran
Use similar supplements

7.
IRCT; 2021-01-11; TrialID: IRCT20201223049816N1
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20201223049816N1

ABSTRACT

Condition:

covid-19.
COVID-19;U07.1

Intervention:

Intervention 1: Intervention group: 1. Phr-160 spray group: PHR spray:160 micrograms per puff, 1 puff every 1 hour up to ten times a day, on days 1 to 10 (use of Damir is required) in addition to the latest covid-19 treatment in the country protocol. Due to the clinical symptoms, this treatment protocol can be continued for 10 days if needed. Intervention 2: Control group: Standard emergency treatment based on protocol, Naproxen 250 mg , Famotidine 40 mg , Vitamin C 500 mg.

Primary outcome:

Percentage of oxygen saturation in two intervention groups after randomization. Timepoint: 1. After randomization at the beginning of the patient's arrival, and every day. Method of measurement: Using Pulse Oximeter.

Criteria:

Inclusion criteria: Both sexes
Ages 15-75
Oxygen saturation percentage between 88 and 93%.
Confirmation of 19 patients using RTPCR.
Confirmation of Covid-19 using CT scan
Signing a informed consent form

Exclusion criteria: Attending another trial in the last three months
pregnancy/lactation
drug sensitivity to the ingredients in the intervention
very high severity of the disease in the emergency room (consciousness less than 15 / oxygen concentration less than 88%, etc)
history of chronic respiratory disease
Previous pulmonary embolism (last three months)

8.
IRCT; 2020-11-08; TrialID: IRCT20200731048257N1
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20200731048257N1

ABSTRACT

Condition:

COVID-19.
COVID-19, virus identified;U07.1

Intervention:

Intervention 1: Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. Intervention 2: Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days.

Primary outcome:

Dyspnea. Timepoint: The beginning of the study and the fifth day. Method of measurement: shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.

Criteria:

Inclusion criteria: informed consent to participate in the study
Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR
Strong clinical suspicion of covid 19 with positive findings in CT Scan
Shortness of breath

Exclusion criteria: Patients with HIV
Patients with cancer undergoing chemotherapy
Patients receiving Immune Mediators
Patients need hospitalization in the intensive care unit
Patients with uncontrolled heart, kidney or liver failure
Pregnant or lactating women
Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)

9.
IRCT; 2020-10-22; TrialID: IRCT20080901001165N63
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20080901001165N63

ABSTRACT

Condition:

COVID-19.
Covid-19;U07.1

Intervention:

Intervention 1: Intervention group: Myrtus nasal spray 1 puff into each nostril every 8 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.

Primary outcome:

Clinical symptoms (dry cough). Timepoint: Baseline (before the initiation of intervention), and day 7 from the initiation. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Baseline (before the initiation of intervention), and day 7 from the initiation. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Baseline (before the initiation of intervention), and day 7 from the initiation. Method of measurement: Thermometer.

Criteria:

Inclusion criteria: Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.

Exclusion criteria: History of allergy to this nasal spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the inpatient care;
Pregnancy;
Lactation.

10.
IRCT; 2020-09-08; TrialID: IRCT20160131026298N6
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20160131026298N6

ABSTRACT

Condition:

COVID-19.
U07.2 COVID-19, virus not identified, COVID-19;U07.2

Intervention:

Intervention 1: Intervention group: Intervention groups will be two ones. Patients in the intervention group will receive the intervention drug (three capsules a day and ten grams of black seed mixture daily) that is made by Talaye sabze tooba company; in addition to the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) . Intervention 2: Control group: The control group will receive the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) .

Primary outcome:

Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Cough scoring form.;Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire.;Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan.

Criteria:

Inclusion criteria: Male or female patients 18 years old and older with Coronavirus Disease 2019 (COVID-19)
Ground glass view at low-dose CT scan
Consciously completed consent form completed by the patient or the patient's supervisor

Exclusion criteria: History of pulmonary malignancy
History of asthma or COPD
History of Disabling disease or malignancy
Liver or kidney disorders

11.
IRCT; 2020-08-04; TrialID: IRCT20160131026298N4
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20160131026298N4

ABSTRACT

Condition:

COVID-19 viral disease.
Coronavirus infection, unspecified;B34.2

Intervention:

Intervention 1: Intervention group: Consumable product includes herbal syrup composed of cyclopeptide fraction with Ziziphus spina-cristi and Pimpinela anisum hydroalcoholic extract and orange peel. The dose of the product is 20 ml every 8 hours after eating, which is prepared by Herbi Pharmed Pharmaceutical Company. Intervention 2: Control group: do not use any drugs for prevention and only follow health protocols to prevent infection.

Primary outcome:

Polymerase chain reaction (PCR) analysis result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Polymerase chain reaction (PCR) analysis.;Liver function test result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Measurement of aspartate aminotransferase (AST) and Alanine transaminase (ALT) factors.;Fragment D-dimer test result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Blood test - Fragment D-dimer measurement.;Measurement of serum iron. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Blood test - Total iron binding capacity factor (TIBC) measurement.;COVID-19 Antibodies. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Measurement of IgG COVID-19 and IgM COVID-19 factors.

Criteria:

Inclusion criteria: People over the age of 18 who have had close contact with a person with COVID-19 in the last 4 days and signed an informed consent form (close contact is defined as those who live at home with an infected person or depending on their employment situation in Less than two meters away from the infected person.) And have no previous or current history of COVID-19.
Age between 18 and 70 years
No previous diagnosis of COVID-19 (if possible, test negative for IgG and IgM antibodies.)
Absence of symptoms such as fever, body aches, olfactory and taste disturbances, cough, shortness of breath, diarrhea in the last 1 month

Exclusion criteria: Current incidence of COVID-19 is confirmed by PCR and clinical signs.
History of autoimmune disease
History of rheumatic disease
Pregnancy and lactation
Age under 18 years
People sensitive to any component of the product
People who can not follow up.
Any clinical reason that may prevent you from entering the study.
Do not take two doses of the drug

12.
IRCT; 2020-06-18; TrialID: IRCT20171105037262N4
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20171105037262N4

ABSTRACT

Condition:

COVID-19.
COVID-19, virus identified;U07.1

Intervention:

Intervention 1: Intervention group: 50 patients with COVID-19 who receive routine antiviral treatment and chloroquine, have more than normal levels of TNF-a, and are at risk of critical disease statement (1-respiratory failure that needs mechanical ventilation, 2-shock, 3-any organ failure, 4-need to be admitted in ICU) will receive subcutaneous injection of anti-TNF-a (adalimumab), 40 mg, in periumbilical region of the abdomen. According to altered clinical and laboratory findings, mentioned dose can be repeated. Intervention 2: Control group: 50 matched patients receiving equal antiviral treatment and chloroquine.

Primary outcome:

Disease severity. Timepoint: At the beginning and end of the intervention. Method of measurement: According to protocol and clinical symptoms.

Criteria:

Inclusion criteria: Having COVID-19
Respiratory distress with over 30 breaths per minute
O2 saturation less than 93% at rest
PaO2/Fio2 less than 300 mmHg
HRCT indicating COVID-19
positive PCR test result

Exclusion criteria:

13.
IRCT; 2020-05-28; TrialID: IRCT20080901001165N60
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20080901001165N60

ABSTRACT

Condition:

COVID-19.
Covid-19;U07.1

Intervention:

Intervention 1: Intervention group: Provita Capsule (each capsule contain vitamin A, E, D, C, B family, Zn, Se, Para-biotic, and inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran) 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Placebo Capsule(contain inactive ingredients similar to Provita's inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran), 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.).

Primary outcome:

Clinical symptoms (dry cough). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Thermometer.

Criteria:

Inclusion criteria:
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.


Exclusion criteria:
History of allergy to the ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.
Impossibility of oral nutrition;

14.
IRCT; 2020-05-27; TrialID: IRCT20080901001165N58
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20080901001165N58

ABSTRACT

Condition:

COVID-19.
Covid-19;U07.1

Intervention:

Intervention 1: Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus. Intervention 2: Control group: Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virusfor the treatment of new corona-virus.

Primary outcome:

Need to receive ICU service (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12). Timepoint: The patient is monitored every 6 hours, but the results are recorded daily in the checklist. Method of measurement: Physical assessment.

Criteria:

Inclusion criteria: Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
The patient/Legal guardian has written consciously and freely consent to participate in the study;
The patient has moderate to severe Corona-Virus associated pneumonia;
In the first 48 hours of hospitalization, the patient did not show an improving trend;
In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;

Exclusion criteria: Multi organ failure;
Pregnancy;
Lactation.

15.
IRCT; 2020-05-23; TrialID: IRCT20080901001165N55
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20080901001165N55

ABSTRACT

Condition:

COVID-19.
Covid-19;U07.1

Intervention:

Intervention 1: Intervention group: NAC inhalation spray (200 microgram NAC/puff) 1 puff every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.

Primary outcome:

Clinical symptoms (dry cough). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Thermometer.

Criteria:

Inclusion criteria:
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.


Exclusion criteria:
History of allergy to this nasal spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.

16.
IRCT; 2020-05-23; TrialID: IRCT20080901001165N56
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20080901001165N56

ABSTRACT

Condition:

COVID-19.
Covid-19;U07.1

Intervention:

Intervention 1: Intervention group: "Curcumin and Resveratrol" Capsule (Each capsule contains 200 mg of curcumin, 200 mg of resveratrol as active ingredients, and 100 mg of lactose as filler), 1 Cap. every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus.

Primary outcome:

Clinical symptoms (dry cough). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Thermometer.

Criteria:

Inclusion criteria:
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.


Exclusion criteria:
History of allergy to the ingredients;
Hypersensitivity reaction while taking this herbal nasal spray;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.

17.
IRCT; 2020-05-14; TrialID: IRCT20080901001165N53
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20080901001165N53

ABSTRACT

Condition:

COVID-19.
Covid-19;U07.1

Intervention:

Intervention 1: Intervention group: Interferon Beta 1a nasal spray 1 puff in each nostril every 6 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.

Primary outcome:

Clinical symptoms (dry cough). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Thermometer.

Criteria:

Inclusion criteria:
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.


Exclusion criteria:
History of allergy to this nasal spray ingredients;
Hypersensitivity reaction while taking this nasal spray;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.
Chronic kidney disease, stage 3 to 5;
Receiving ACEI/ARB group;

18.
IRCT; 2020-05-05; TrialID: IRCT20080901001165N52
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20080901001165N52

ABSTRACT

Condition:

COVID-19.
Covid-19;U07.1

Intervention:

Intervention 1: Intervention group: At Day 1: Amp. Methylprednisolone 500mg IV infusion over 1 hour. At Day 2 and 3, Amp. Methylprednisolone 250mg IV infusion over 1 hour. At Day 4 and 5, Amp. Methylprednisolone100mg IV infusion over 1 hour. Then, Tab. Prednisolone 25mg, per oral, daily, until the day of discharge, then Tab. Prednisolone will gradually taper off over during 1 month. All patients will receive routine treatment according to the latest national guideline. Intervention 2: Control group: Includes patients who will not receive high-dose of glucocorticoids during hospitalization. All patients will receive routine treatment according to the latest national guideline.

Primary outcome:

Need to receive ICU service (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12). Timepoint: The patient is monitored every 6 hours, but the results are recorded daily in the checklist. Method of measurement: Physical assessment.

Criteria:

Inclusion criteria: Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
The patient has written consciously and freely consent to participate in the study;
The patient has moderate to severe Corona-Virus associated pneumonia;
In the first 48 hours of hospitalization, the patient did not show an improving trend;
In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;

Exclusion criteria: History of hypersensitivity reaction to glucocorticoids;
Recent hospitalization and treatment history due to COVID-19;
Receive antiviral drugs before including into this study, such as: Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir;
Receiving Methylprednisolone pulse before including into this study;
Uncontrolled severe chronic illnesses, including heart failure, kidney failure, liver failure, active cancer (history of chemotherapy within recent month), diabetes;
Receiving immunosuppressing /immunomodulating agents, such as systemic glucocorticoids.
Pregnancy;
Lactation.

19.
IRCT; 2020-04-30; TrialID: IRCT20160131026298N3
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20160131026298N3

ABSTRACT

Condition:

COVID-19.
U07.2 COVID-19, virus not identified, COVID-19;U07.2

Intervention:

Intervention 1: Intervention group: The medicinal product includes a capsule composed of two herbs(salix ,lambs quarter). The amount of each of these substances in the capsule is 250 mg. The dosage of the product is three capsules a day, which is half an hour before each meal. This product is prepared by Armaghan Sabz Araz Teb Pharmaceutical Company.In this group, common medical drug is also consumed according to the latest protocol of the Ministry of Health. Intervention 2: Control group: Patient in control group use common medicine based on the latest protocol of the Ministry of Health and placebo.

Primary outcome:

Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Standard cough questionnaire.;Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire.;Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan.

Criteria:

Inclusion criteria: Male or female patients 18 years old and older with COVID-19
positive coronavirus 19 PCR
Ground glass view at low-dose CT scan
Arterial oxygen saturation less than 93%
Consciously completed consent form completed by the patient or the patient's supervisor

Exclusion criteria: History of pulmonary malignancy
History of asthma or COPD
History of Disabling disease or malignancy
Liver or kidney disorders

20.
IRCT; 2020-04-20; TrialID: IRCT20160131026298N2
Clinical Trial Register | ICTRP | ID: ictrp-IRCT20160131026298N2

ABSTRACT

Condition:

COVID-19.
U07.2COVID-19, virus not identified, COVID-19;U07.2

Intervention:

Intervention 1: Intervention group:The group uses the following herbal medicine in addition to the current medicine for Covid-19: Drug Name: Pinene-Hydronoplactone-Ribonucleoic-Abbreviation: PHR160 - Drug Form: Inhaler Spray --- Ingredients: Sineol Menthol Crocin Safranol Alpha Tojun Oleic Acid Linoleic Acid Linolenic AcidIt was extracted from natural products found in 7 plant species by steam distillation method. These herbs have previously had a single, double or triple human consumption history. Effectives per puff: 160 micrograms How to use PHR160: Determine the dosage approach for the above product based on the following: 1. Due to the volume of the nozzle output and pump MDIs and the presence of propylant (HFA gas) and alcohol in the product concentration of essential oils and herbal compounds in the total MDI is about 0.3%. Therefore, the total amount of soluble natural substances available per puff is less than 300 nL or 270 mg, which, of course, reaches a limited proportion in the lungs. 1-20 g / kg of human body weight and these compounds are considered very safe and high dosage is much lower than the toxic range indicated and is 1/100 toxic in the case of essential oils.3. Products available on the market such as Eucalyptus Barrage incense, Eucalyptus dyne incense Pulmonary doses of essential oils are similar to our product compounds in excess of 30mg. Of the amount in each puff investigated product is less than 1/100 of the amount above 0.4. External products mainly used in Aroma Therapy Ascents, MBC Aerosol, Primatene Mist are examples of those with higher doses of essential oil.5.Refruitment time to discuss the use or inhalation of the above product 30-45 In this case, the maximum time interval of 1 hour of awakening has been suggested for this product to

Primary outcome:

Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Standard cough questionnaire.;Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire.;Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan.

Criteria:

Inclusion criteria: Male or female patients 18-65 years with COVID-19 confirmed by PCR (with mild involvement) - Ground glass view on CT scan - Arterial oxygen saturation less than 93% - Breathing more than 24 times per minute - At the Beginning onset of the disease - Negative pregnancy test in women - Completion of informed consent form by patient or supervisor

Exclusion criteria: Oral ulcer or malignancy - history of pulmonary malignancy - history of asthma or COPD

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