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
Conditions
Interventions
Two initial arms (all oral therapeutics):
1. Doubase C (30 mg Uvaria brevistipitata extract
6 mg Haroungana madagascariensis extract)
70 kg: 4 tablets thrice for 7 days
2. Chloroquine/hydroxychloroquine + Azithromycin
Hydroxychloroquine 2x200 mg for 10 days
PLUS
Azithromycin 500 mg Day 1
aged under 18 years old, pregnancy, comorbidities meaning that the serum creatinine > 1.5 mg/dL, estimating glomerular filtration rate (eGFR) < 60 mL/min / 1.73m
Sponsors
Creppat Laboratories SARL
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Asymptomatic subjects 2. Requiring mechanical ventilation 3. Creatinine > 110 umol/L, eGFR 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. SARS-CoV2 viral load measured using PCR on days 7 and 14 of randomisation 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 | — |
Countries
Congo, Democratic Republic
Contacts
Public ContactJean-Robert;Jean-Robert Makulo;Makulo
;
Outcome results
None listed