COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43130

Col Anurag Khera

vksashindran@gmail.com

2020-04-28

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Age > 18 years <br/ >All sexes <br/ >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. <br/ > Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI) <br/ > Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). <br/ > Severe: Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or ARDS or septic shock <br/ > <br/ >Laboratory confirmed SARS CoV-2 infection within last 10d or SARS CoV-2 test result pending with a high clinical suspicion as defined by: <br/ >Cough of <10d duration <br/ >Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air <br/ >No alternative explanation for respiratory symptoms <br/ >Scheduled for admission or enrolled within 48h of hospital admission <br/ >

Children < 18 years <br/ >Pregnant or lactating women <br/ >Symptoms of acute respiratory tract infection for > 10d before randomisation <br/ >More than 48h have elapsed between meeting inclusion criteria and randomisation <br/ >Seizure disorder <br/ >Known case of G6PD deficiency <br/ >Diagnosed long QT syndrome <br/ >QTc >500ms on ECG within 72h prior to enrolment <br/ >Chronic haemodialysis or GFR <20 ml/min <br/ >Psoriasis or porphyria cutanea tarda <br/ >Severe liver disease <br/ >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 <br/ >Receipt of >1 dose of HCQ / AZT in 10 days prior to enrolment <br/ >Known allergic reactions to HCQ or azithromycin <br/ >Inability to take/receive enteral medication <br/ >Inability to be contacted on D14 for clinical outcome assessment (unless died in hospital)

3

Director General Armed Forces Medical Services

18

85

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

300

COVID Ordinal Outcomes Scale is defined as: <br/ >1. Death <br/ >2. Hospitalised on invasive mechanical ventilation or extracorporeal mechanical ventilation ( ECMO) <br/ >3. Hospitalised on non-invasive ventilation or high-flow nasal cannula oxygen therapy <br/ >4. Hospitalised on supplemental oxygen <br/ >5. Hospitalised not on supplemental oxygen <br/ >6. Not hospitalised with limitation of activity (due to continued symptoms) <br/ >7. Not hospitalised without limitation in activity (no symptoms)Timepoint: D14 <br/ >

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 3

[{"arm_notes": "400mg", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "600mg", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]