Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B338- Other specified viral diseases
Conditions
Interventions
Intervention1: Hydroxychloroquine sulfate (HCQs): HCQ 400mg BD on D1 and 400 mg OD on D2 - 5
Intervention2: Hydroxychloroquine sulphate high dose HCQh): HCQ 600 mg BD on D1 and 600 mg OD on D2 - 5
I
Sponsors
Director General Armed Forces Medical Services
Eligibility
Inclusion criteria
Inclusion criteria: Age > 18 years All sexes Case definitions for inclusion in the study will include mild, moderately severe and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020. Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI) Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). Severe: Severe Pneumonia (with respiratory rate >=30/minute and/or SpO2 Laboratory confirmed SARS CoV-2 infection within last 10d or SARS CoV-2 test result pending with a high clinical suspicion as defined by: Cough of Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 No alternative explanation for respiratory symptoms Scheduled for admission or enrolled within 48h of hospital admission
Exclusion criteria
Exclusion criteria: Children Pregnant or lactating women Symptoms of acute respiratory tract infection for > 10d before randomisation More than 48h have elapsed between meeting inclusion criteria and randomisation Seizure disorder Known case of G6PD deficiency Diagnosed long QT syndrome QTc >500ms on ECG within 72h prior to enrolment Chronic haemodialysis or GFR Psoriasis or porphyria cutanea tarda Severe liver disease Any subject who has received the following drugs in the 12h period before enrolment or who is likely to receive the following during the period of therapy with HCQ / HCQ + AZT / AZT: amiodarone, cimetidine, phenobarbitone, phenytoin, digoxin Receipt of >1 dose of HCQ / AZT in 10 days prior to enrolment Known allergic reactions to HCQ or azithromycin Inability to take/receive enteral medication Inability to be contacted on D14 for clinical outcome assessment (unless died in hospital)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| COVID Ordinal Outcomes Scale is defined as: 1. Death 2. Hospitalised on invasive mechanical ventilation or extracorporeal mechanical ventilation ( ECMO) 3. Hospitalised on non-invasive ventilation or high-flow nasal cannula oxygen therapy 4. Hospitalised on supplemental oxygen 5. Hospitalised not on supplemental oxygen 6. Not hospitalised with limitation of activity (due to continued symptoms) 7. Not hospitalised without limitation in activity (no symptoms)Timepoint: D14 | — |
Secondary
| Measure | Time frame |
|---|---|
| All location, all-cause mortality assessed on D14 (Time frame- assessed on 14th day of starting treatment) Vital status of patient will be ascertained from medical record review, phone call to patient or proxy Timepoint: D14;All location, all-cause mortality on D28 (Time frame- assessed on 28th day of starting treatment) Vital status of patient will be ascertained from medical record. review, phone call to patient or proxy Timepoint: D28;Compare groups with regards to acute kidney injury to D28 (The number of patients who have acute kidney injury between starting treatment and 28th day will be determined) Timepoint: D28;Compare groups with regards to acute pancreatitis to D28 (The number of patients who have acute pancreatitis between starting treatment and 28th day will be determined) Timepoint: D28;Compare groups with regards to atrial or ventricular arrhythmia to D28 (The number of patients who have atrial or ventricular arrhythmias between starting treatment and 28th day will be determined) Timepoint: D28;Compare groups with regards to cardiac arrest to D28 (The number of patients who have cardiac arrests between starting treatment and 28th day will be determined) Timepoint: D28;Compare groups with regards to elevation of aspartate aminotransferase to D28 (The number of patients who have aspartate aminotransferase level more than two times upper limit of normal between starting treatment and 28th day will be determined) Timepoint: D28;Compare groups with regards to neutropenia, lymphopaenia, anaemia or thrombocytopenia to D28 (The number of patients who have neutropenia, lymphopaenia, anaemia or thrombocytopenia between starting treatment and 28th day will be determined) Timepoint: D28;Compare groups with regards to seizures to D28 (The number of patients who have seizures between starting treatment and 28th day will be determined) Timepoint: D28;Compare groups with regards to severe dermatologic reaction to D28 (The number of patients who experience se | — |
Countries
India
Contacts
Public ContactCol Anurag Khera
Armed Forces Medical Services
Outcome results
None listed