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

Phase 1

• Conditions: COVID-19; MedDRA version: 20.0Level: LLTClassification code 10038700Term: Respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001614-38-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 282

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 141
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 141

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 :
oheart failure with severely reduced ejection fraction (30%)
oknown 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 )
opatients on Macrolides during the last week before admission
*For other treatment strata, see arm-specific protocols.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified