Evaluation of the efficacy and safety of Favipiravir and Interferon beta compared to Lopinavir/Ritonavir and Interferon beta in patients with COVID-19
A phase 3 clinical trial with parallel group, open-label, 60 patients, block randomized method
Settings and conduct:
This study will be conducted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas.The study population is 60 patients with COVID-19 (30 patients in control group and 30 in study group).
Participants/Inclusion and exclusion criteria:
Inclusion criteria:Age ≥18 years, positive polymerase chain reaction (PCR) test for COVID-19, primary clinical symptoms, hospitalized, and signing informed consent.
Exclusion Criteria: Underlying diseases, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, and peptic ulcers, acute and chronic renal failure, peptic ulcers, history of allergy to studied drugs, and pregnancy and breastfeeding.
Group A will be patients receiving Favipiravir and Interferon beta-1a, and Group B will be patients receiving Lopinavir/Ritonavir and Interferon beta-1a.
Main outcome variables:
Checking the viral load, fever, O2 saturation,
Evaluation of duration of hospitalization, C-reactive protein,
Occurrence of adverse drug reactions