An open-label, multicenter, randomized, controlled adaptive study to evaluate the efficacy and safety of investigational therapeutics for the treatment of hospitalized patients with mild to moderate novel coronavirus disease (COVID-19) in Kinshasa, Democratic Republic of the Congo

Phase 3

Completed

• Conditions: COVID-19 patients with mild or moderate clinical stage/WHO classification followed up at university clinics in Kinshasa during the second and third waves of the COVID-19; Infections and Infestations

• Registration Number: ISRCTN16254682
• Lead Sponsor: Creppat Laboratories SAR

Brief Summary

Abstract results see attached file 44329_OtherUnpublishedResults.pdf (added 18/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-31
• Study Start: 2023-10-24
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

1. Male or non-pregnant female adult =18 years of age at time of enrolment. Children > 12 years of age and pregnant women may be included if recommended by the DSMB
2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR at a Government approved lab. from nasopharyngeal or oropharyngeal swab, within 48 hours prior to screening
3. No severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation
4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures
5. Understands and agrees to comply with planned study procedures
6. Agrees to the collection of NP/OP swabs and venous blood per protocol
7. Agrees to not be enrolled in another trial for the full duration of the study
8. Creatinine = 110 umol/L, creatinine clearance rate (eGFR) = 60 ml / min / 1.73m2, AST and ALT = 40 IU/L

Exclusion Criteria

1. Asymptomatic subjects
2. Requiring mechanical ventilation
3. Creatinine > 110 umol/L, eGFR < 60 ml / min / 1.73m2, ALT/AST > 2 × ULN or TBIL > 2 × ULN
4. Pregnancy or breastfeeding
5. Anticipated transfer to another hospital which is not a study site within 72 hours
6. History of allergy to any investigational product ingredients
7. Shortness of breath in resting position
8. Known prolonged QT syndrome
9. Use of concomitant medications that prolong the QT/QTc interval
10. Subjects who have severe underlying diseases that affect survival including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding and severe malnutrition
11. Subjects who in the opinion of the investigators after assessing all relevant parameters are unsuitable for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with mild/moderate COVID-19 whose clinical condition worsened measured using SpO2 < 90 % (severe clinical COVID-19) from baseline up to days 7 and 14 from randomization

Secondary Outcome Measures

Name	Time	Method
<br> 1. SARS-CoV2 viral load measured using PCR on days 7 and 14 of randomisation<br> 2. EKG tracing (prolongation of the QTc interval), results of creatinine, ALAT, ASAT, hemoglobin, WBC and Platelets measured using standard medical laboratory methods at baseline and on the 7th and 14th day<br><br>