COVID-19 trials registries data warehouse

http://en.irct.ir/trial/60723

Dr. Afshin Zarghi

Mpajouhesh@sbmu.ac.ir

2022-01-03

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Laboratory confirmation of Coronavirus disease-19 (COVID-19) virus by reverse transcription- polymerase chain reaction (RT-PCR) Moderate-severity disease (respiration rate more than 30 per minute, oxygen saturation more than 94%, or pulmonary infiltration less than 50% in both lungs) Age over 18 years Body mass index less than 40 kilogram per square meters No immunosuppressive diseases, including primary and secondary immunodeficiency, consumption of immunosuppressive drugs, organ transplants, chemotherapy or radiotherapy Patient willingness to participate in the study Existence of oral tolerance Non-pregnant and non-lactating women Not receiving antiviral drugs and other effective drugs in the treatment of COVID-19 in this clinical course No history of severe drug allergy and anaphylactic shock

Not completing the 5-day treatment period, not completing all visits or laboratory tests Development of severe drug hypersensitivity and anaphylactic shock during the study Occurrence of oral intolerance in the clinical course

2

Shahid Beheshti University of Medical Sciences

18

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

Hospitalization during the follow-up period Body temperature Respiratory rate Oxygen saturation

Phase 3

[{"arm_notes": "", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]