The Therapeutic Effect of Molnupiravir in COVID-19 Patients

Phase 3

Conditions: COVID-19.
COVID-19, virus identified
U07.1

Registration Number: IRCT20210901052358N1

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospitalization during the follow-up period. Timepoint: Seventh day from the beginning of treatment. Method of measurement: Patient medical record.;Body temperature. Timepoint: Days 1 (start of treatment), 3, 5 and 7. Method of measurement: Thermometer.;Respiratory rate. Timepoint: Days 1 (start of treatment), 3, 5 and 7. Method of measurement: Physical examination by physician.;Oxygen saturation. Timepoint: Days 1 (start of treatment), 3, 5 and 7. Method of measurement: Pulseoxymeter.

Secondary Outcome Measures

Name	Time	Method
Serum CRP level. Timepoint: Days 1 (start of treatment) and 7. Method of measurement: Laboratory report.;Lymphocyte count. Timepoint: Days 1 (start of treatment) and 7. Method of measurement: Laboratory report.;Platelet count. Timepoint: Days 1 (start of treatment) and 7. Method of measurement: Laboratory report.;Neutrophil: Lymphocyte ratio. Timepoint: Days 1 (start of treatment) and 7. Method of measurement: Laboratory report.