COVID-19 trials registries data warehouse

http://en.irct.ir/trial/50780

Dr. Mohammad Samiei

Samiei.moh@gmail.com

2020-09-15

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

18 years and older, both sexes Having home contact, unmasked contact with a patient with Covid-19 confirmed by RT-PCR or clinical evidence or radiography of pneumonia and acute respiratory distress syndrome (ARDS); No clinical signs of Covid-19 (fever, cough, dyspnea, shortness of breath, sore throat, extreme tiredness, digestive problems); No chronic respiratory problems or other illnesses that are mistaken for symptoms of COVID-19

Involvement with any other ongoing studies. Pregnant or breast feeding woman or with positive pregnancy test result for fetal safety Severe liver disease as a strong confounding factor Severe renal failure as a strong confounding factor Refusal by attending physician for no clinical equipoise Advanced active malignancy as a strong confounding factor Patient in other clinical trials for COVID-19 within 30 days before/after ICF as a confounding factor/s Other patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, severe renal failure, and etc. May impact primary and other clinical endpoints- Known allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications for patient protection purposes Other uncontrolled disease, as judged by investigators that may influence study endpoint and other clinical outcome

2

Tabriz University of Medical Sciences

18

100

Iran

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1300

Test for the presence or absence of nucleic acid in the corona virus Serum IgM and IgG levels

Phase 3

[{"arm_notes": "", "treatment_id": 240, "treatment_name": "Bromhexine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]