Covid-19: A randomized, open-label, adaptive, proof-of- concept clinical trial of new antiviral drug candidates against SARS-CoV-2.

General information
EudraCT Number: 2020-001614-38
CTA Load Date: 2020-04-06
Sponsor’s protocol code number: S63935
Start date recruitment: 1970-01-01
Start date recruitment (EU): 1970-01-01
Gender
Population Female: Yes
Population Male: Yes
Age group(s)
Children (2-11 years): No
Age Range > 18 yrs: No
Adults (18-64 years): Yes
Elderly (≥ 65 years): Yes
Type of trial subjects
Healthy Volunteers: No
Patients: Yes
Specific vulnerable populations: Yes
Trial type and phase
Randomised: Yes
Has the IMP been designated in this indication as an orphan drug: No
Amendment type: not available
Human Pharmacology (Phase I): No
Therapeutic Exploratory (Phase II): Yes
Therapeutic Confirmatory (Phase III): No
Therapeutic Use (Phase IV): No
Disease or condition under investigation
Medical condition(s) being investigated: COVID-19
Medical condition in easily understood language: COVID-19
MedDRA HLGT Code: 10021879
MedDRA HLGT Name: Infections - pathogen unspecified
MedDRA HLT Code: 10021902
MedDRA HLT Name: Infections NEC
MedDRA LLT Code: 10038700
MedDRA LLT Name: Respiratory infection
Condition being studied is a rare disease: No
Information on the site
National competent authority: Belgium - FPS Health-DGM
Institution name: Jan Yperman Ziekenhuis
Department name: not available
Street: not available
Town: not available
Postal code: not available
Country: Belgium
Phone number: not available
Principal inclusion and exclusion criteria
Principal inclusion criteria:

1. Subject (≥18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness not related to the investigational research study will be obtained.
2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
3. Male or non-pregnant female adult ≥18 years of age at time of enrolment.
4. Has a confirmed diagnosis of SARS-CoV-2 infection within 72 hours prior to randomization, defined as either:
a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen or
b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses
5. Illness of any duration, and at least one of the following:
a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or
b. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or
c. Requiring mechanical ventilation and/or supplemental oxygen.

Principal exclusion criteria:

1. ALT/AST > 5 times the upper limit of normal.
2. Pregnancy or breast feeding.
3. Allergy to any study medication
4. Any medical condition which would impose an unacceptable safety hazard by participation to the study.
5. Study drug specific exclusion criteria:
*for Azithromycin :
o heart failure with severely reduced ejection fraction (30%)
o known prolonged long QT interval on ECG (> 470 msec males and > 480 females with Fridericia criteria; for patients with ventricular conduction delay the use of Rautaharju formula is also allowed )
o patients on Macrolides during the last week before admission
*For other treatment strata, see arm-specific protocols.