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1.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-317183

ABSTRACT

Background: The combination of sofosbuvir (SOF) and daclatasvir (DCV) has shown preliminary efficacy for patients with COVID-19 in five open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir and daclatasvir to standard care improved clinical endpoints in hospitalized patients with moderate or severe COVID-19. Methods: This was a placebo-controlled, randomized clinical trial in adults with moderate or severe COVID-19 admitted to 19 hospitals in Iran. Patients were randomized to SOF/DCV 400/60mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O 2 saturation <95%, and compatible symptoms. The primary endpoint was discharge from hospital within 10 days of first treatment. The trial is registered on Iran Registry of Clinical Trials under IRCT20200624047908N1 available at https://www.irct.ir/trial/49198.Results: Between July and October 2020, 1083 patients were allocated to either the SOF/DCV treatment arm (n=541) or matching placebo (n=542). The primary endpoint was achieved by 358 / 541 (66%) in the SOF/DCV arm and 370 /542 (68%) in controls (relative risk = 0.97, 95% CI = 0.89-1.05). The in-hospital death rates were 58/541 (11%) in the SOF/DCV group versus 53/542 (10%) in the placebo group (relative risk = 1.1, 95% CI = 0.77 to 1.56). Conclusions: We observed no significant effect of SOF/DCV versus placebo on the rate of hospital discharge or survival in hospitalized COVID-19 patients. However, the patient population was generally severe cases that may have been too advanced for antiviral drugs to be effective. Trial Registration: Iran Registry of Clinical Trials under IRCT20200624047908N1 available at https://www.irct.ir/trial/49198.Funding: This trial was sponsored by Abadan University of Medical Sciences and funded by the International Treatment Preparedness Coalition (grant number ITPC-2020)Declaration of Interests: S.Merat has received travel grants from and is a stockholder of Fanavaran Rojan Mohaghegh Daru Co. ANB and HNB are stockholders of Fanavaran Rojan Mohaghegh Daru Co. All other authors: none to declare.Ethics Approval Statement: The study protocol has been approved by the Abadan Faculty of Medicine Sciences Institutional Review Board and the Iranian Registry of Clinical Trials (IRCT) registry team.

2.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-312522

ABSTRACT

Background: & AimCoronavirus 2019 (COVID-19) outbreak in the Middle East was initially reported in Qom-Iran. Clinical and epidemiologic and mortality risk factors details have not been already fully explained.MethodIn a retrospective study, the hospitalized adult patients with laboratory diagnosed COVID-19 between February 25 to March 20, 2020 were enrolled. A checklist including demographic, clinical, laboratorial, imaging, and treatment data was completed for each of the participant. The data were extracted from electronic medical records. In case of lack of information, a member of the research team contacted them via phone. All the dead patients and the first one hundred survived patients with these criteria were enrolled in the study. Outcome defined as death or discharge of patients.ResultsOf admitted patients, 200 patients who had been discharged or died were involved in this study. The majority of them were male (56%). The mean age of all patients was 62.63 ± 14.9. Co-morbidity was reported in 124 (62%) patients in which hypertension was the most common. The most frequent clinical presentations were dyspnea in 169 (84.5%), cough in 150 (75%), and fatigue/weakness in 123 (61.5%) patients. The main complications were respiratory failure and acute respiratory distress syndrome with prevalence of 143 (71.5%) and 105 (52.5%), accordingly. Multiple logistic models showed that decline of hemoglobin level (OR = 10.09), neutrophilia (OR = 3.48), high blood urea nitrogen (OR = 4.29,), SpO2 ≤ 90% (OR = 3.38), and presence of patchy consolidation (OR = 6.81) were associated with poor outcome.ConclusionCOVID-19 disease has multiple aspects. CT scan findings, complete blood count with differential, high blood urea nitrogen and SpO2 are related to mortality. Hence needs to pay serious attention during admitting and surveillance, particularly among elderly patients and who with preexisting morbidities.

3.
J Antimicrob Chemother ; 77(3): 758-766, 2022 02 23.
Article in English | MEDLINE | ID: covidwho-1545994

ABSTRACT

BACKGROUND: The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. METHODS: This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. RESULTS: Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77-1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. CONCLUSIONS: We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.


Subject(s)
COVID-19 , Sofosbuvir , Adult , Antiviral Agents/therapeutic use , Carbamates , Humans , Imidazoles , Pyrrolidines , SARS-CoV-2 , Sofosbuvir/therapeutic use , Treatment Outcome , Valine/analogs & derivatives
4.
Int Immunopharmacol ; 95: 107522, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1385749

ABSTRACT

BACKGROUND: We examined the safety and efficacy of a treatment protocol containing Favipiravir for the treatment of SARS-CoV-2. METHODS: We did a multicenter randomized open-labeled clinical trial on moderate to severe cases infections of SARS-CoV-2. Patients with typical ground glass appearance on chest computerized tomography scan (CT scan) and oxygen saturation (SpO2) of less than 93% were enrolled. They were randomly allocated into Favipiravir (1.6 gr loading, 1.8 gr daily) and Lopinavir/Ritonavir (800/200 mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO2 after 5 min discontinuation of supplemental oxygen, and length of hospital stay were quantified and compared in the two groups. RESULTS: 380 patients were randomly allocated into Favipiravir (193) and Lopinavir/Ritonavir (187) groups in 13 centers. The number of deaths, intubations, and ICU admissions were not significantly different (26, 27, 31 and 21, 17, 25 respectively). Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups) (p = 0.61). Time to clinical recovery in the Favipiravir group was similar to Lopinavir/Ritonavir group (HR = 0.94, 95% CI 0.75 - 1.17) and likewise the changes in the daily SpO2 after discontinuation of supplemental oxygen (p = 0.46) CONCLUSION: Adding Favipiravir to the treatment protocol did not reduce the number of ICU admissions or intubations or In-hospital mortality compared to Lopinavir/Ritonavir regimen. It also did not shorten time to clinical recovery and length of hospital stay.


Subject(s)
Amides/administration & dosage , Amides/adverse effects , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , COVID-19/drug therapy , Pyrazines/administration & dosage , Pyrazines/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Drug Therapy, Combination , Female , Humans , Hydroxychloroquine/administration & dosage , Hydroxychloroquine/adverse effects , Intubation , Kaplan-Meier Estimate , Length of Stay , Lopinavir/administration & dosage , Lopinavir/adverse effects , Male , Middle Aged , Oxygen/blood , Ritonavir/administration & dosage , Ritonavir/adverse effects , Severity of Illness Index , Treatment Outcome , Young Adult
5.
Iran J Public Health ; 50(4): 825-830, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1287032

ABSTRACT

BACKGROUND: We aimed to verify the association between blood group systems and prognosis of SARS-Cov-2 disease. METHODS: In this cross-sectional study, 329 patients infected with SARS-Cov-2 diagnosed based on their COVID-19 RT-PCR results and chest CT scans, were enrolled in the study. These patients were admitted to Kamkar Arab Nia Hospital, Qom, Iran from March to June 2020. Their blood groups and RH were determined, and demographic characteristics and clinical signs of patients were recorded. The patients' temperature and peripheral capillary oxygen saturation levels (SpO2) were measured. Finally, the duration of hospitalization, intubation, and death rate were also analyzed. RESULTS: The results of the patients' blood group analysis were as follows: 129(39.2%) patients had A type, 66(20.1%) B type, 21(6.4%) AB type, and 113(34.3%) O type. Of 329 patients, 297 (90.3%) had Rh antigen. The dead cases were higher in O blood type at 13 cases (11.5%). Considering the positive and negative rhesus antigen, 31 (10.4%) and 1 (3.1%) were dead respectively, but the difference was not statically significant. As for the A group, the mean of admission duration (8.4±6.1 days) was not significantly different from the B group (8.8 ±7.2 days). AB group with a mean (7.4 ±4.4 days) was not significantly different from the O group (7.8 ± 5.4 days). There was no significant difference in the duration of hospitalization in RH patients, positive or negative. B blood group showed a significant association with the time interval to return to normal oxygen levels. CONCLUSION: Blood type was not associated with COVID-19 death rate, nor was it associated with admission duration. B blood group showed a significant association with the time interval to return to normal oxygen levels.

6.
Int J Infect Dis ; 107: 264-267, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1210963

ABSTRACT

BACKGROUND: Since the beginning of the Coronavirus disease 2019 (COVID-19) pandemic there have been contradictions and speculations about the relationship between vitamin D and COVID-19. Given that there is an association between vitamin D deficiency and some diseases - including cancer, autoimmune disease and some infectious diseases - a higher incidence and mortality rate in the vitamin-D-deficient COVID-19 population was not a surprise; conversely, some research would argue this relationship. Considering these contradictions, this study aimed to determine the relationship between prognosis and vitamin D level in cases with COVID-19. METHODS: In this cross-sectional study, 329 confirmed cases of COVID-19 - who were admitted to Kamkar-ArabNia Hospital in Qom city, Iran from March-July 2020 - were categorized into three groups according to vitamin D serum levels (ng/ml): sufficient (>30), insufficient (20-30) and deficient (<20). Prognosis was determined across the groups. RESULTS: There was a significant difference in hospital stay between patients with sufficient and insufficient vitamin D levels (P = 0.007). Adjusting vitamin D levels for confounding variables, linear regression underscored significant differences in the association between length of hospitalization and lower vitamin D levels, with a longer stay noted in insufficient groups (P = 0.002). However, there was no significant difference in the time interval to return to normal oxygen level (from SpO2 < 93%) or death rate between groups (P > 0.05). CONCLUSION: There was a significant association between hospital stay and lower serum vitamin D levels. However, the relationship between vitamin D status and death rate or the time interval to return to normal oxygen levels was not significant.


Subject(s)
COVID-19/mortality , SARS-CoV-2 , Vitamin D/blood , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/blood , Cross-Sectional Studies , Female , Humans , Length of Stay , Male , Middle Aged , Prognosis , Vitamin D Deficiency/complications , Young Adult
8.
BMC Infect Dis ; 20(1): 646, 2020 Sep 01.
Article in English | MEDLINE | ID: covidwho-740368

ABSTRACT

BACKGROUND: COVID-19 is known as a new viral infection. Viral-bacterial co-infections are one of the biggest medical concerns, resulting in increased mortality rates. To date, few studies have investigated bacterial superinfections in COVID-19 patients. Hence, we designed the current study on COVID-19 patients admitted to ICUs. METHODS: Nineteen patients admitted to our ICUs were enrolled in this study. To detect COVID-19, reverse transcription real-time polymerase chain reaction was performed. Endotracheal aspirate samples were also collected and cultured on different media to support the growth of the bacteria. After incubation, formed colonies on the media were identified using Gram staining and other biochemical tests. Antimicrobial susceptibility testing was carried out based on the CLSI recommendations. RESULTS: Of nineteen COVID-19 patients, 11 (58%) patients were male and 8 (42%) were female, with a mean age of ~ 67 years old. The average ICU length of stay was ~ 15 days and at the end of the study, 18 cases (95%) expired and only was 1 case (5%) discharged. In total, all patients were found positive for bacterial infections, including seventeen Acinetobacter baumannii (90%) and two Staphylococcus aureus (10%) strains. There was no difference in the bacteria species detected in any of the sampling points. Seventeen of 17 strains of Acinetobacter baumannii were resistant to the evaluated antibiotics. No metallo-beta-lactamases -producing Acinetobacter baumannii strain was found. One of the Staphylococcus aureus isolates was detected as methicillin-resistant Staphylococcus aureus and isolated from the patient who died, while another Staphylococcus aureus strain was susceptible to tested drugs and identified as methicillin-sensitive Staphylococcus aureus. CONCLUSIONS: Our findings emphasize the concern of superinfection in COVID-19 patients due to Acinetobacter baumannii and Staphylococcus aureus. Consequently, it is important to pay attention to bacterial co-infections in critical patients positive for COVID-19.


Subject(s)
Acinetobacter Infections/complications , Acinetobacter baumannii/isolation & purification , Betacoronavirus/physiology , Coinfection/epidemiology , Coronavirus Infections/complications , Pneumonia, Viral/complications , Staphylococcal Infections/complications , Staphylococcus aureus/isolation & purification , Acinetobacter Infections/epidemiology , Acinetobacter Infections/microbiology , Acinetobacter baumannii/drug effects , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/pharmacology , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Diabetes Complications/epidemiology , Female , Heart Diseases/complications , Humans , Hypertension/complications , Intensive Care Units , Male , Methicillin-Resistant Staphylococcus aureus/drug effects , Methicillin-Resistant Staphylococcus aureus/isolation & purification , Middle Aged , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , Respiratory System/microbiology , SARS-CoV-2 , Staphylococcal Infections/epidemiology , Staphylococcal Infections/microbiology , Staphylococcus aureus/drug effects
9.
Arch Iran Med ; 23(7): 503-504, 2020 07 01.
Article in English | MEDLINE | ID: covidwho-642220

ABSTRACT

The novel coronavirus, formerly named as 2019 novel coronavirus (2019-nCov) caused a rapidly spreading epidemic of severe acute respiratory syndrome (SARS) in Wuhan, China and thereafter, progressed globally to form a pandemic of coronavirus disease 2019 (COVID-19) in numerous countries; and now confirmed cases are reported from several provinces of Iran. Now various medical centers, clinicians and researchers around the world share their data and experiences about COVID-19 in order to participate in the global attempt of controlling the pandemic. The current report investigates the clinical presentations and paraclinical findings of the first confirmed cases and mortalities in the initiation of the outbreak of COVID-19 in Iran.


Subject(s)
Betacoronavirus , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Aged , COVID-19 , COVID-19 Testing , Clinical Laboratory Techniques , Coronavirus Infections/complications , Coronavirus Infections/therapy , Fatal Outcome , Humans , Iran , Male , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/therapy , SARS-CoV-2
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