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1.
Iran J Pharm Res ; 20(3): 553-559, 2021.
Article in English | MEDLINE | ID: covidwho-1623790

ABSTRACT

COVID-19 pandemic has created a global health challenge. Many pharmaceuticals have been repurposed as potential treatments, though many have not been promising. Due to the inflammatory and destructive effects of the virus on alveolar cells, the effect of exogenous surfactant was assessed as a potential treatment of lung dysfunction in COVID-19 patients. In this pilot study of the clinical trial, 49 patients aged 35-80 years with COVID-19 admitted in ICU entered the study (22 patients intubated and 23 had face masks; 4 patients in the control arm). The treatment arm patients received two consecutive doses of surfactant. P/F ratio (based on serial blood gas analyses before and 12 hours after 2 doses of surfactant) and also, clinical outcomes were assessed.in COVID-19 adult patients, surfactant significantly improved pulmonary P/F ratio both in intubated and face mask COVID-19 patients (increasing from 119.2 ± 51.7 to 179.4 ± 115.5). The rate of extubation was much better than similar country-wide studies. Surfactant significantly alleviates the respiratory status in moderate to severe COVID-19 ARDS with two consecutive 100 mg doses of surfactant (with 6 hours' interval) though previous studies have been controversial, regarding the effect of surfactant in general forms of ARDS. Higher doses might have better effects, mandating more trials.

2.
Arch Iran Med ; 24(4): 333-338, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1498430

ABSTRACT

BACKGROUND: Decision-making on allocating scarce medical resources is crucial in the context of a strong health system reaction to the coronavirus disease 2019 (COVID-19) pandemic. Therefore, understanding the risk factors related to a high mortality rate can enable the physicians for a better decision-making process. METHODS: Information was collected regarding clinical, demographic, and epidemiological features of the definite COVID-19 cases. Through Cox regression and statistical analysis, the risk factors related to mortality were determined. The Kaplan-Meier curve was used to estimate survival function and measure the mean length of living time in the patients. RESULTS: Among about 3000 patients admitted in the Taleghani hospital as outpatients with suspicious signs and symptoms of COVID-19 in 2 months, 214 people were confirmed positive for this virus using the polymerase chain reaction (PCR) technique. Median time to death was 30 days. In this population, 24.29% of the patients died and 24.76% of them were admitted to the ICU (intensive care unit) during hospitalization. The results of Multivariate Cox regression Analysis showed that factors including age (HR, 1.031; 95% CI, 1.001-1.062; P value=0.04), and C-reactive protein (CRP) (HR, 1.007; 95% CI, 1.000-1.015; P value=0.04) could independently predict mortality. Furthermore, the results showed that age above 59 years directly increased mortality rate and decreased survival among our study population. CONCLUSION: Predictor factors play an important role in decisions on public health policy-making. Our findings suggested that advanced age and CRP were independent mortality rate predictors in the admitted patients.


Subject(s)
COVID-19/diagnosis , COVID-19/mortality , Adult , Age Factors , Aged , COVID-19/complications , Clinical Decision-Making , Female , Hospital Mortality , Hospitalization , Humans , Iran , Male , Middle Aged , Prognosis , Proportional Hazards Models , Retrospective Studies , Risk Factors , Survival Rate
3.
J Cell Mol Med ; 25(22): 10554-10564, 2021 11.
Article in English | MEDLINE | ID: covidwho-1462824

ABSTRACT

Acute respiratory distress syndrome (ARDS) is the most common cause of death in COVID-19 patients. The cytokine storm is the main driver of the severity and magnitude of ARDS. Placenta-derived decidua stromal cells (DSCs) have a stronger immunosuppressive effect than other sources of mesenchymal stromal cells. Safety and efficacy study included 10 patients with a median age of 50 (range 14-68) years with COVID-19-induced ARDS. DSCs were administered 1-2 times at a dose of 1 × 106 /kg. End points were safety and efficacy by survival, oxygenation and effects on levels of cytokines. Oxygenation levels increased from a median of 80.5% (range 69-88) to 95% (range 78-99) (p = 0.012), and pulmonary infiltrates disappeared in all patients. Levels of IL-6 decreased from a median of 69.3 (range 35.0-253.4) to 11 (range 4.0-38.3) pg/ml (p = 0.018), and CRP decreased from 69 (range 5-169) to 6 (range 2-31) mg/ml (p = 0.028). Two patients died, one of a myocardial infarction and the other of multiple organ failure, diagnosed before the DSC therapy. The other patients recovered and left the intensive care unit (ICU) within a median of 6 (range 3-12) days. DSC therapy is safe and capable of improving oxygenation, decreasing inflammatory cytokine level and clearing pulmonary infiltrates in patients with COVID-19.


Subject(s)
COVID-19/drug therapy , Cell Transplantation/methods , Cytokine Release Syndrome/therapy , Respiratory Distress Syndrome/virology , Stromal Cells/transplantation , Adolescent , Adult , Aged , COVID-19/complications , COVID-19/therapy , Cell Transplantation/adverse effects , Cytokine Release Syndrome/etiology , Cytokines/blood , Female , Humans , Length of Stay , Male , Middle Aged , Placenta/cytology , Pregnancy , Respiratory Distress Syndrome/therapy , Stromal Cells/physiology , Treatment Outcome
4.
Iran J Microbiol ; 13(4): 495-501, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1436440

ABSTRACT

Background and Objectives: There are conflicting studies on the prevalence of mediastinal lymphadenopathy (LAP) and its relationship to the prognosis of COVID-19 disease. The prevalence varied from 3.4 to 66 percent and more prevalent in patients who died. This study aimed to investigate the mediastinal lymphadenopathy and the disease progression in COVID-19 patients. Materials and Methods: In this case-control study, 195 COVID-19 patients were divided into two groups, with the mediastinal lymphadenopathy and without it. In these groups, demographic characteristics, underlying diseases, laboratory results, and outcomes were compared. Results: The median age in the LAP group was higher than the opposite group (62 vs. 58.5; p= 0.037). SpO2 (85% vs. 90%; P <0.001), lymphocyte count (760 vs. 969; p= 0.02), Neutrophil-to-Lymphocyte Ratio (5.53 vs. 4.41; p= 0.02), and ESR (36 vs. 29; p= 0.03) were significantly correlated with the presence of lymphadenopathy, using the Mann-Whitney Wilcoxon rank test. ICU admission (65.71% vs. 36.87; p= 0.003), mechanical ventilation (31.42% vs. 13.75%; p= 0.022), disease severity (65.71% vs. 40%; p <0.01), length of hospital stay (9 vs. 7; p= 0.039) and mortality rate (40% vs. 21.25%; p= 0.034) were more predominantly observed in the LAP group, using the χ2 test. There was no apparent difference in sex and the underlying diseases among the two groups. Conclusion: This observation showed a relatively high prevalence of mediastinal lymphadenopathy in COVID-19 patients, which was more common in the elderly with low oxygen saturation. Therefore, LAP may lead to further intensive care needs, more use of mechanical ventilation, high severity of disease, and mortality rate.

5.
Iranian Journal of Microbiology ; 13(4):495-501, 2021.
Article in English | Academic Search Complete | ID: covidwho-1361071

ABSTRACT

Background and Objectives: There are conflicting studies on the prevalence of mediastinal lymphadenopathy (LAP) and its relationship to the prognosis of COVID-19 disease. The prevalence varied from 3.4 to 66 percent and more prevalent in patients who died. This study aimed to investigate the mediastinal lymphadenopathy and the disease progression in COVID-19 patients. Materials and Methods: In this case-control study, 195 COVID-19 patients were divided into two groups, with the mediastinal lymphadenopathy and without it. In these groups, demographic characteristics, underlying diseases, laboratory results, and outcomes were compared. Results: The median age in the LAP group was higher than the opposite group (62 vs. 58.5;p= 0.037). SpO2 (85% vs. 90%;P <0.001), lymphocyte count (760 vs. 969;p= 0.02), Neutrophil-to-Lymphocyte Ratio (5.53 vs. 4.41;p= 0.02), and ESR (36 vs. 29;p= 0.03) were significantly correlated with the presence of lymphadenopathy, using the Mann-Whitney Wilcoxon rank test. ICU admission (65.71% vs. 36.87;p= 0.003), mechanical ventilation (31.42% vs. 13.75%;p= 0.022), disease severity (65.71% vs. 40%;p <0.01), length of hospital stay (9 vs. 7;p= 0.039) and mortality rate (40% vs. 21.25%;p= 0.034) were more predominantly observed in the LAP group, using the χ2 test. There was no apparent difference in sex and the underlying diseases among the two groups. Conclusion: This observation showed a relatively high prevalence of mediastinal lymphadenopathy in COVID-19 patients, which was more common in the elderly with low oxygen saturation. Therefore, LAP may lead to further intensive care needs, more use of mechanical ventilation, high severity of disease, and mortality rate. [ABSTRACT FROM AUTHOR] Copyright of Iranian Journal of Microbiology is the property of Tehran University of Medical Sciences and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

6.
Iran J Psychiatry ; 16(3): 362-369, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1326081

ABSTRACT

Objective: The recent escalated numbers of subjected COVID-19 patients and mortality rates have alerted the general population and authorities to its effects not only on physical health but also on different aspects of the society such as mental health. This study assesses the general mental health and immediate psychological impacts in hospitalized patients with COVID-19. Method : In this cross-sectional study, 88 patients from two tertiary hospitals in Tehran agreed to complete the surveys. The Impact of Event Scale-Revised (IES-R) and 12 item General Health questionnaire (GHQ-12) were used to evaluate mental health and impact of disease. Epidemiological and sociodemographic information entailing underlying diseases was assess by a researcher-made questionnaire. Results: We found that the psychological impact of the current pandemic is mild to moderate. During the initial phase of the pandemic, the intellectual engagements, inducing post event stress is not yet entirely developed. However, patients had a moderate to high probability of psychiatric morbidity with 63.6% and 28.4%, respectively. Conclusion: The effect of such viral pandemic on mental health is inevitable. As we conducted the study in the dire times of the outbreak, patients showed a high probability of psychiatric morbidity. On the other hand, since the study was done in the initial phase of the epidemic, we detected mild effects of the epidemic on PTSD in COVID-19 patients. Furthermore, several psychosocial protective programs should be implicated to address the mental complications.

7.
Iran J Psychiatry ; 16(3): 250-259, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1326079

ABSTRACT

Objective: COVID-19, which is an international concern by far, had fundamental impacts on mental health of medical staff. Healthcare workers are the high-risk group to endure the emotional outcomes brought about by the outbreak. This study assesses the mental consequences of healthcare workers during the acute phase of COVID-19 pandemic in Tehran. Method : We conducted a cross-sectional study on healthcare workers from two tertiary referral hospitals in Tehran province. A total of 222 of the staff participated in the study. Our questionnaires comprised Impact of Event Scale-Revised (IES-R) and 12-item General Health Questionnaire (GHQ-12), which were handed to participants to obtain data on their general mental problems in addition to the psychological impacts of the evolving virus on this particular group. Epidemiologic and sociodemographic information of participants, level of perceiving exposure to disease, and underlying diseases of each of them were gathered during the recruitment period. Results: Results showed high probabilities (98.2%) in mental disorders among healthcare workers. Since our study was done during the initial phase of the pandemic, development of mental issues due to the newly emerged infectious virus was expected. However, we recorded mild (41.4%) to moderate (31.5%) impact of this novel virus. The possibility of having mental problems was much higher in females, assistant nurses, individuals with lower education, and those who provided care for COVID-19 patients. Conclusion: COVID-19 has brought about increased distress among healthcare workers. Noticeably, the forefront group in combating this virus bear the most emotional complications. Thus, efforts should be taken into practice to provide proper psychological support for this vulnerable group.

8.
Transfus Apher Sci ; 60(4): 103141, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1193493

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is an emerged pandemic disease with no specific treatment. One of the potential treatments in newly found infectious disease is plasma exchange (PE) with convalescent plasma transfusion (CPT). This case series aimed to evaluate the primary PE and CPT in five Iranian COVID-19 patients. METHODS: Five patients with confirmed COVID-19 who had acute respiratory distress syndrome and were supported by mechanical ventilation were treated with two consecutive PE containing fresh frozen plasma (FFP) of healthy donors and 0.9 % saline solution containing 5 % human albumin. Thereafter, CPT was performed just like PE, except that the FFP in this step was substituted with convalescent ABO-matched plasma. Clinical and laboratory factors were evaluated before and after treatments. RESULTS: Three to Four patients showed lower body temperature and improved oxygen saturation as well as reduced laboratory factors such as c-reactive protein, lactate dehydrogenase, creatine phosphokinase (total and myocardial isoform), aspartate aminotransferase, blood urea nitrogen, bilirubin (total and direct), D-dimer, interleukin-6, and CD4+/CD8 + T cells ratio initially after PE and continued to improve so that they were discharged. One patient due to secondary hemophagocytic lymphohistiocytosis and extensive lung fungal infection was expired. DISCUSSION: Overall, the PE followed by CPT was beneficial in reducing acute inflammation led to a considerable improvement in patients' clinical features. It seems that PE along with CPT could provide clearance of pro-inflammatory mediators as well as the positive effects of CPT. Controlled studies are required to confirm the effect of PE/CPT compared with other therapeutic approaches.


Subject(s)
COVID-19/therapy , Plasma Exchange , Plasma , SARS-CoV-2/immunology , Aged , Anti-Infective Agents/therapeutic use , Antibodies, Viral/blood , Biomarkers , Blood Donors , Body Temperature , C-Reactive Protein/analysis , COVID-19/blood , COVID-19/diagnostic imaging , Combined Modality Therapy , Female , Humans , Immunization, Passive , Inflammation Mediators/blood , Interleukin-6/blood , Lung/diagnostic imaging , Male , Middle Aged , Oxygen/blood , Respiration, Artificial
9.
JMIR Res Protoc ; 10(2): e23316, 2021 Feb 02.
Article in English | MEDLINE | ID: covidwho-1067549

ABSTRACT

BACKGROUND: COVID-19 was declared a pandemic on March 11, 2020. Given that the severe shortage of hospital beds has led to early discharge and insufficient patient education on home care routines and isolation protocols, the close follow-up of patients and their immediate relatives is an integral part of transitioning from hospital care to home care for patients with COVID-19. OBJECTIVE: We designed the Tele-COVID-19 prospective cohort to follow-up with COVID-19 patients in Tehran, Iran, and improve health care delivery and the recording of postdischarge patients' clinical profiles. METHODS: All adult patients who were admitted to the COVID-19 wards of teaching hospitals in Tehran, Iran were eligible to participate in this cohort study. At baseline, patients were recruited from 4 major hospitals from March 9, 2020 to May 20, 2020. Telephone follow-ups, which were led by volunteer medical students, were conducted on postdischarge days 1-3, 5, 7, 10, and 14. We collected data on a range of sociodemographic, epidemiological, and clinical characteristics by using a standard questionnaire. RESULTS: Of the 950 patients with confirmed COVID-19 who were approached, 823 (response rate: 86.6%) consented and were enrolled into the cohort. Of the 823 participants, 449 (54.5%) were male. The mean age of participants was 50.1 years (SD 12.6 years). During the initial data collection phase, more than 5000 phone calls were made and over 577 reports of critical patients who were in need of urgent medical attention were recorded. CONCLUSIONS: The Tele-COVID-19 cohort will provide patients with sufficient education on home care and isolation, and medical advice on care and the proper use of drugs. In addition, by preventing unnecessary hospital returns and providing information on household SARS-CoV-2 transmission as early as possible, this cohort will help with effective disease management in resource-limited settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23316.

10.
Acta Biomed ; 91(4): e2020145, 2020 11 10.
Article in English | MEDLINE | ID: covidwho-1058710

ABSTRACT

INTRODUCTION: Recently, Covid 19 as a fatal virus has been known as the cause of the pandemic. Different number of the mortality rate in various societies have been reported. However, it seems the underlying comorbidities increase the risk of mortality and the severity of presentation. In this study we evaluated the pattern of presentation of COVID-19 among cancerous patients in terms of severity. METHOD: between 20th February to 22nd April of 2020, among 214 hospitalized patients because of COVID-19. 41 patients revealed the cancer as a synchronous comorbidity. These patients based on the severity of COVID-19 infection presentation were divided to mild and severe groups. Then, the demographic characteristics, manifestation and laboratory data between these groups were compared. RESULT: about 19 (46.34%) of 41 cases were categorized as severe forms of COVID-19 with malignancy. The mean age of severe groups was significantly higher (P=0.00). Dyspnea (48.78%), cough (46.34%) and myalgia (24.39%) were the most common clinical features among cancerous patients with COVID-19.  diarrhea and nearly cough caused significant effects on severe form of presentation of COVID-19 infection (P=0.05, P=0.06, respectively). Hematological cancers were the most frequent types of cancer among these patients (46.34%). White Blood Cell counts were significantly lower in severe groups (P=0.03, P=.0.06, respectively). C-reactive protein is another item that nearly significantly was higher in severe groups of cancerous patients (P=0.06). CONCLUSION: The elderly age, the positive chemotherapy history, diarrhea, cough, declined WBC, PLT and elevated CRP correlated with a severe form of this infection in malignant cases.


Subject(s)
COVID-19/complications , COVID-19/diagnosis , Neoplasms/complications , Adult , Aged , Aged, 80 and over , Female , Hospitalization , Humans , Male , Middle Aged , Retrospective Studies , Severity of Illness Index
11.
Caspian J Intern Med ; 11(Suppl 1): 520-526, 2020.
Article in English | MEDLINE | ID: covidwho-1022323

ABSTRACT

Background: COVID-19 targets the liver and there is no available data about liver injury due to mild to moderate form of COVID-19. In this study, we evaluated the risk factors associated with liver injury in NON-ICU admitted COVID-19 patients. Methods: in this retrospective study, 102 eligible adult participants admitted in the ward were included. The patients with previous history of liver disease were excluded. The patients with AST or ALT or bilirubin more than normal ranges were allocated in liver injury group and patients with normal ranges of them were categorized in non-liver injury. Characteristics and laboratory data were analyzed between these two groups. Results: The mean age of the population was 55.13± 17.02 years old. The most common symptom was fever (45.8%). The most frequent co-morbidity was hypertension (25%). 65 patients had liver injury (63.72%). CRP were significantly higher in liver injury group (P=0.01). Univariate analysis reported ALKP, and CRP was associated significantly with liver injury (P=0.04, OR= 1.003, Cl 95%= 1.000-1.007; P=0.03, OR= 1.009, Cl 95%= 1.000- 1.017, respectively). No independent factor was detected in multivariate analysis. Based on the Spearman's rank correlation coefficients CRP correlated significantly with AST (r=0.22, P=0.00). Moreover, neutrophil and CRP, correlated with ALT (r=0.01, P=0.90; r=0.23, P=0.02, respectively). Conclusion: No independent factor was detected to predict liver injury chance due to COVID-19. However, CRP had a significant association with it. It appears that the role of inflammatory pathways in liver damage was due to COVID-19.

12.
Caspian J Intern Med ; 11(Suppl 1): 512-519, 2020.
Article in English | MEDLINE | ID: covidwho-1022322

ABSTRACT

Background: The pandemic situation created an overwhelmed needs for ICU facilities, according to this problem, the need of accurate management of facilities represents boldness. In this study, prognostic risk factors for ICU admission among COVID-19 hospitalized patients were evaluated. Methods: From 22 February to April 20, 2020. A total of 214 COVID-19 patients participated in this study. The included patients were between 18- 80 years old, and the patients who previously admitted for COVID-19 were excluded. The comorbid medical conditions, admission laboratory, demographic data, and first manifestations were analyzed between two groups, including ICU and non-ICU admitted patients. The statistical analysis, univariate and multivariate analysis were afforded. The value of the predictors in the risk assessment of ICU admission was estimated. Results: 55(25.7%) patients were admitted in ICU. The ICU admitted patient's mortality rate was about 68%. The age was significantly higher among ICU admission group (P=0.03). Admission O2 saturation was significantly lower among ICU admitted patients (P=0.00). The kidney disease and malignancy history were more frequent in ICU-admitted patients (P=0.04, P=0.00). Myalgia was the clinical manifestation that significantly presented more frequent in ICU-admitted patients. INR, CRP, ESR, HB, and lymphocyte were significantly different between two groups. After multivariable analysis, admission O2 saturation, hematocrit, CRP and myalgia could significantly predict the risk of ICU admission. Furthermore, the value of predictors was estimated in our study. Conclusion: Based on our results, the admission O2 saturation, HCT, CRP levels at first admission and myalgia presentation could be considered as the valuable predictors of ICU admission.

13.
Gastroenterol Hepatol Bed Bench ; 13(4): 400-404, 2020.
Article in English | MEDLINE | ID: covidwho-1008494

ABSTRACT

Today, COVID-19 pneumonia causes global concern. The World Health Organization (WHO) has reported many mortalities from this disease all around the world. Therefore, recognizing new cases of COVID-19 is crucial during this pandemic. Many studies have shown that COVID-19 has a broad spectrum of signs and symptoms, including GI and cutaneous manifestations. Previous studies have reported liver enzyme changes as well as diarrhea as a common GI manifestation of COVID-19. However, there are few reports about COVID-19 synchronous cutaneous and liver involvement. Additionally, there are few reports about intrahepatic cholestasis in COVID-19 patients. In this article, a confirmed case of COVID-19 with vasculopathy-related cutaneous manifestation and liver cholestasis is reported. A 67-year-old Iranian woman was admitted to Taleghani Hospital with epigastric pain, vomiting, anosmia, rising liver enzyme levels, fever, itching, and skin rashes. Skin and liver biopsies were performed during the patient's admission; the results suggested vasculopathy-related cutaneous lesion and liver cholestasis. Plasmapheresis was initiated and all manifestations disappeared after treatment. All atypical presentations, including cutaneous lesions and liver manifestations, should be considered as COVID-19 and evaluated.

14.
Gastroenterol Hepatol Bed Bench ; 13(4): 405-409, 2020.
Article in English | MEDLINE | ID: covidwho-1008357

ABSTRACT

COVID-19 is a new contagious viral pneumonia with various signs and symptoms, including loss of consciousness, liver injury, and cerebrovascular accident; however, there is little data on the manifestation and outcome of COVID-19 in liver transplant patients. Moreover, because transplant units in Iran were closed from the first day of the COVID-19 pandemic, accurate data about nosocomial COVID-19 and the liver transplant setting is not available. In this article, we introduce a liver transplant recipient with a final fatal outcome, who had had neurological manifestations, and whose COVID-19 manifestations began in the hospital within 2 days of transplant surgery.

15.
Trials ; 21(1): 919, 2020 Nov 11.
Article in English | MEDLINE | ID: covidwho-917940

ABSTRACT

OBJECTIVES: Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under mechanical ventilation TRIAL DESIGN: Single centre, two arm, parallel group (1:1 allocation ratio), randomised superiority trial with blinded care and outcome assessment. PARTICIPANTS: Inclusion criteria: Adult COVID-19 patients admitted to the ICU in Modarres hospital, Tehran, Iran (age range of 18 to 99 years) with moderate to severe ARDS (based on definition of P/F ratio) requiring auxiliary respiratory devices (either intubation or face mask). EXCLUSION CRITERIA: ● Existence of a major underlying pulmonary disease in addition to COVID-19 ● Underlying congenital heart disease ● Patients needing extracorporeal membrane oxygenation (ECMO) ● ARDS primarily due to any other reason rather than COVID-19 ● The primary source of pulmonary involvement was bacterial pneumonia or any other etiology except for COVID-10 induced lung involvement ● Those who refused to continue the study (either the patient or their family) ● any patient had any sign of healing before entering the study leading to discharge from ICU in less than 12 hours INTERVENTION AND COMPARATOR: In the intervention group, the dose of the drug is a vial containing 4 ml, equivalent to 100 mg, which is prescribed for an adult weighing about 70 kg each time, and if the patient's weight is much lower or higher, it will be adjusted accordingly. Surfactant is prescribed inside the trachea in two doses, starting on the day of intubation with a second dose 6 hours later. The control group will receive the same volume of normal saline, based on weight, administered into the trachea with the same time schedule. MAIN OUTCOMES: 30 days mortality; patient mortality during stay in ICU up to 30 days; ICU length of stay up to 30 days; Time under mechanical ventilation up to 30 days. RANDOMISATION: After the participant enters the study, i.e. after the qualification of the patients in the trial is confirmed and their informed written consent is taken, we will use a simple randomisation method using a table of random numbers. In order to hide the random allocation process, a central randomisation approach will be used and the random sequence will be at the disposal of one of the researchers, excluding the principal investigator. BLINDING (MASKING): Participants, healthcare providers and the principal investigator assessing the outcomes will all be blinded to the group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 60 participants will be randomised in a 1:1 allocation ratio (30 patients allocated to the intervention group and 30 patients allocated to the control group). TRIAL STATUS: The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020. TRIAL REGISTRATION: IRCT registration number: IRCT20091201002804N12 Registration date: 1st June 2020, 1399/03/12 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Pulmonary Surfactants , Respiration, Artificial/methods , Adult , Betacoronavirus , COVID-19 , Dose-Response Relationship, Drug , Double-Blind Method , Drug Dosage Calculations , Drug Monitoring/methods , Female , Humans , Male , Mortality , Pandemics , Pulmonary Surfactants/administration & dosage , Pulmonary Surfactants/adverse effects , Randomized Controlled Trials as Topic , SARS-CoV-2 , Surface-Active Agents/administration & dosage , Surface-Active Agents/adverse effects , Treatment Outcome
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