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Add on to Azythromycine, Phytomedicine and/or Antimalarial Drug vs Hydroxychloroquine in Uncomplicated COVID-19 Patients

NCT04502342 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-08-07

No results posted yet for this study

Summary

The phase II clinical trial, with three arms and at rate of 10 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non inferiority test aimed to compare the efficacy and safety in add on to Azithromycin, an antimalarial drug, a treatment combination of the antimalrial drug with an antiviral phytomedicine versus Hydroxychloroquine in COVID-19 patients without complications.

During the treatment, viral clearance, adverse effects related to treatment, and symptoms progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied.

Conditions

  • Covid19

Interventions

COMBINATION_PRODUCT

Hydroxycloroquine and Azythromycine

dual treatment with Hydroxycloroquine and Azythromycine

COMBINATION_PRODUCT

Cospherunate/Azythromycine

dual treatment with Cospherunate and Azythromycine

COMBINATION_PRODUCT

Cospherunate/Phytomedicine/Azythromycien

triple treatment with Cospherunate, Asen and Azythromycine

Sponsors & Collaborators

  • Institute for Research and Development of Medicinal and Food Plants of Guinea

    lead OTHER

Principal Investigators

  • Mamadou A Baldé · RDIMFPG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-08-30
Completion
2020-09-30

Countries

  • Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502342 on ClinicalTrials.gov