COVID-19 pneumonia. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: Patients allocated to treatment group were given 8 mg bromhexine tablet (Tolid Daroo), four times a day, orally for 28 days. Patients also received Supportive treat
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age =18 years at time of signing Informed Consent Form Laboratory (RT-PCR) confirmed infection with COVID-19 Lung involvement confirmed with chest imaging Hospitalized with a SaO2/SPO2=94% on room air or PaO2/FiO2 ratio <300mgHg =12 days since illness onset Willingness of study participant to accept randomization to any assigned treatment arm Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study
Exclusion criteria
Exclusion criteria: Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely Severe liver disease (e.g. Child Pugh score = C, AST>5 times upper limit) Pregnant or breastfeeding, or positive pregnancy test Patients with known severe renal impairment (estimated glomerular filtration rate =30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis Will be transferred to another hospital which is not the study site within 72 hours Receipt of any experimental treatment for 2019-nCoV (off-label, or trial related) within the 30 days prior to the time of the screening evaluation Allergic to the Bromhexine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinical Improvement (TTCI). Timepoint: Daily. Method of measurement: TTCI is defined as the time (in days) from initiation of the study treatment (active or placebo) until a decline of two categories from admission status occur.1. Hospital discharge or meeting discharge criteria; 2. Non-ICU hospitalization, not requiring supplemental oxygen; 3. Non-ICU hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 4. ICU/non-ICU hospitalization, requiring NIV/ HFNC therapy; 5. ICU hospitalization, requiring IMV; 6. Death.;Need for invasive mechanical ventilation. Timepoint: Daily. Method of measurement: Medical record.;Death. Timepoint: At the end of the study. Method of measurement: Medical record. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical status. Timepoint: Days 7, 14, 21, 28. Method of measurement: Medical record.;Time to hospital discharge. Timepoint: Daily. Method of measurement: Medical record.;All-cause mortality. Timepoint: Daily. Method of measurement: Medical record.;Duration of mechanical ventilation. Timepoint: Daily. Method of measurement: Medical record.;Duration of extracorporeal membrane oxygenation (ECMO). Timepoint: Daily. Method of measurement: Medical record.;Duration of supplemental oxygen. Timepoint: Daily. Method of measurement: Medical record.;Duration of hospitalization. Timepoint: Daily. Method of measurement: Medical record.;Time to RT-PCR negativity in upper and lower respiratory tract specimen. Timepoint: Daily. Method of measurement: Medical record.;Change (reduction) in viral load in upper and lower respiratory tract specimen. Timepoint: Daily. Method of measurement: Medical record. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactPayam Tabarsi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed