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Column | Value |
---|---|
Trial registration number | IRCT20210914052480N2 |
Full text link
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
morteza_izadi@yahoo.com |
Registration date
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2022-07-07 |
Recruitment status
Last imported at : March 20, 2023, 12:23 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
Study design
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
Allocation
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
Design
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
Masking
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
Center
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
single-center |
Study aim
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Treatment |
Inclusion criteria
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Living in a family with at least one infected person with COVID-19 Not having pulmonary involvement Not having symptoms like chest wall pain and dysnea suggesting pulmonary involvement Positive PCR test of COVID-19 Patient with COVID-19 symptoms lesser than 3 days Patients satisfied with consumption of oral medication Blood oxygen saturation above 93 percents |
Exclusion criteria
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Patients under 18 years old Having underlying diseases such as uncontrolled diabetes, uncontrolled blood pressure, liver and heart disease and kidney, heart and liver failure History of any of the diseases including hepatitis B or C, HIV, autoimmune diseases and immunodeficiency History of hepatocellular disease, liver failure and heart failure of liver tests more than 3 times normal History of allergy to antiviral drugs Existence of thrombocytopenia (platelets under 100000) History of recent COVID-19 vaccination lesser than 7 days being pregnant breastfeeding |
Number of arms
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2 |
Funding
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Bagheiat-allah University of Medical Sciences |
Inclusion age min
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
Inclusion age max
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
100 |
Countries
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
Type of patients
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Mild disease at enrollment |
Severity scale
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
1: Mild disease at enrollment |
Total sample size
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
500 |
primary outcome
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Negative pcr test or increase in CT NUMBER after intervention fever serum CRP inflammatory factor The level of oxygen saturation in the blood of patients dry cough existance dyspnea muscular pain pulse rate respiratory rate blood pressure serum ESR inflammatory factor |
Notes
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
|
Phase
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 2/Phase 3 |
Arms
Last imported at : July 8, 2022, 12:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "oral molnopiravir 200 mg daily for up to five days after the intervention, with diphenhydramine syrup / vitamin C tablet / vitamin D tablet / famotidine 40 mg tablet every 12 hours", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " for five days, with diphenhydramine syrup, vitamin C tablets, vitamin D tablets, famotidine 40mg tablets every 12 hours, and naproxen 250 in case of fever and muscle aches. They will receive it once or twice a day", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |