COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=13420

James Arkinstall

media@dndi.org

2020-10-07

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

From the Master study : 1. Male or female patients, 2. Adults over or equal to 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening. 4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) over or equal to 94%. 5. Corrected QT interval (QTc – Bazett and Fridericia) < 480 msec on ECG. 6. Signed written consent from the patient or his/her representative. 7. Accepting and having the ability to be reached by telephone throughout the study. 8. Having designated a contact person who can be contacted in case of emergency. For the Immuno Ancillary study 1. Able and willing to provide consent for the immunological ancillary study 2. Able and willing to perform all study visits for a duration of 12 months after treatment start

From the Master Study 1. Abnormal physical examination findings: • respiratory rate over or equal to 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients over or equal to 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis, • recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L). 2. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency. 3. Feeling unwell for more than 7 days prior to screening. 4. Severe cardiopathy or history of arrhythmia, renal or liver insufficiency. 5. History of congenital or acquired long QT-interval, family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction, family history of sudden cardiac death, sudden cardiac death, bradycardia < 50 bpm. 6. Past history of retinopathy, such as spots or dark strings floating in the field of vision (floaters), blurred or fluctuating vision, impaired colour vision, dark or empty areas in vision. 7. History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. 8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months. 9. Pregnancy based on urine pregnancy test at screening or breast-feeding, unless recommended by the Data and Safety Monitoring Board after the first interim analysis. 10. Prior treatment with. lopinavir/ritonavir within 29 days prior to screening except if patients are receiving the same regimen as planned in this study. Patients randomised to lopinavir/ritonavir will stop their current treatment and switch to the IP lopinavir/ ritonavir. If randomised to other arms, patients will continue their current treatment with lopinavir/ritonavir. 11. Prior treatment with hydroxychloroquine within 29 days prior to screening or on-going at screening.

3

DNDi

18

100

Equatorial Guinea;Ethiopia;Ghana;Kenya;Mozambique;Congo;Sudan

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1000

1) Seroconversion for SARS-CoV-2 IgM; IgA and IgG by treatment arm and patient outcome;2) Quantitative levels of antibodies (IgM; IgG; IgA) specific for SARS-CoV-2;3) Frequency of SARS-CoV-2-specific effector/memory CD4+ and CD8+ T cells ;4) Proportions of (poly)functional SARS-CoV-2-specific T cells

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 958, "treatment_name": "Paracetamol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]