Treatment of COVID19 : A randomised controlled trial

Phase 3

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B338- Other specified viral diseases

Registration Number: CTRI/2020/04/024904

Lead Sponsor: Director General Armed Forces Medical Services

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 < 90% in room air) or ARDS or septic shock

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 <10d duration

Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air

No alternative explanation for respiratory symptoms

Scheduled for admission or enrolled within 48h of hospital admission

Exclusion Criteria

Children < 18 years

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 <20 ml/min

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)