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Trial - IRCT20210914052480N2


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)

First author
Last imported at : July 8, 2022, 12:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Gholamhosein Alishiri

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"}]