This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days. Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days
200mg of Hydroxychloroquine two times per day will be given to patients for seven days in Test group, and Patients in Control group will be given a stat dose of 400mg Hydroxychloroquine tablets two times per day.
Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.
Mohammad Sadegh Bagheri Baghdasht
Tehran, Iran
Mortality
In-hospital mortality
Time frame: Up to 28 days
long of hospitalization
long of hospitalization
Time frame: Up to 28 days
Laboratory Treatment Response (Blood cell count)
Laboratory Treatment Response; return of blood cell count to normal
Time frame: Up to 28 days
Laboratory Treatment Response (CRP )
Laboratory Treatment Response; return of CRP values to normal
Time frame: Up to 28 days
Dyspnea
shortness of breath based on symptoms of Dyspnea and questioning the patient
Time frame: Up to 28 days
Oxygen saturation without supplemental oxygen.
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Time frame: Up to 28 days
Oxygen therapy
Oxygen therapy maximum flow during the day (lit/min)
Time frame: Up to 28 days
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