COVID-19. COVID-19
Conditions
Interventions
Intervention 1: Intervention group: Group receiving Favipiravir plus Hydroxychloroquine. Stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) and stat dose of two 200mg Hydroxychloroquine tab
Sponsors
Iran University of Medical Sciences
Bagheiat-allah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19 Requiring hospitalization because of: Patient's oxygen saturation less than 93% OR Requiring hospitalization because of: GCS score less than 15 OR Requiring hospitalization because of: systolic blood pressure less than 100 or 30 mmHg decrease in systolic blood pressure from the level prior to current illness OR Requiring hospitalization because of: renal failure (creatinine 1.5 times the previous measurement in the last 7 days OR Requiring hospitalization because of: liver failure (AST and ALT 3 times upper limit of normal) Patient's age between 16 and 100 years Signed informed consent form.
Exclusion criteria
Exclusion criteria: Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir, ...) Chronic liver failure Chronic Renal Failure Patients with acute problems whose survival is expected to be less than 48 hours HIV patients A history of gastrointestinal bleeding Pregnancy and lactation QT interval exceeds 500 ms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Admission to intensive care unit. Timepoint: Once (when admitted to intensive care unit). Method of measurement: Hospital records. | — |
Secondary
| Measure | Time frame |
|---|---|
| In-hopital mortality. Timepoint: once. Method of measurement: Patient medical records.;Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records.;Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area. Timepoint: CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one. Method of measurement: Patient CT scan.;Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits.;Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes. Timepoint: 4 times a day while in the wards. Method of measurement: Observation.;Oxygen therapy maximum flow during the day (lit/min). Timepoint: Daily. Method of measurement: Patient medical records.;Allergic drug reaction. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.;Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.;Clinical improvement. Timepoint: Daily. Method of measurement: One of the following may happen to the patient: Oxygen saturation reaches above 93% and stays above 93%, the patient does not need oxygen therapy and stays in the same position, discharge by the treating physician. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Biganeh
Bagheiat-allah University of Medical Sciences
Outcome results
None listed