Clinical trial NCT04501965: Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients
Official title: Evaluation de l'efficacité et de la tolérance de Quinquina et d'un phytomédicament " ACAR " en Comparaison Avec l'Hydroxychloroquine Chez Des Adultes Malades de Covid-19 Sans symptômes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Keywords: Treatment; clinical research
Lead sponsor: Institute for Research and Development of Medicinal and Food Plants of Guinea
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible consenting symptom-free patients with COVID-19 confirmed by a positive Polymerase Chain Reaction test were subjected to the 10 days of treatment allocated to each of the 3 arms of the trial. Virological clearance is assessed on days 3, 6 and 14. Side effects are noted throughout the trial period. Clinical, paraclinical and laboratory examinations are occasionally provided. Viral clearance, side effects, and the onset of COVID symptoms are evaluated and the data is statistically processed.
Primary purpose: TREATMENT

Brief summary: Our previous work on plants has indicated significant antimalarial and antiviral activities. Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and anti-inflammatory properties.

The phase II clinical trial, with three arms and at a rate of 77 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non-inferiority test aimed at comparing the therapeutic impact in "add on" to Azithromycin, phytomedicines versus Hydroxychloroquine in asymptomatic COVID-19 patients.

After 10 days of treatment, viral clearance and symptom 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

Detailed description: All consenting subjects who meet the inclusion criteria will benefit from an individual file which will include data relating to general information, the complete clinical examination and the paraclinical examination. They are distributed randomly into three parallel groups, each arm having a different treatment modality. A balanced randomization by permutation block of 5 will be applied using the "Randomizer for Clinical Trial" application developed by the company Medsharing). Laboratory examinations are carried out according to the procedures and method by laboratories accredited in Guinea for the diagnosis of COVID19. Data is encoded, entered and processed using statistical software.

The comparison between the three cohorts will be made using either the Anova test for continuous variables or the chi-square test for categorical variables. The rate of change over time of virologic clearance, fever and other symptoms values as well as the differences for these rates between treatment arms will be tested using mixed-effects modeling.

The biological samples will be stored at the biobank of the National Institute of Public Health of Guinea.

Eligibility criteria: Inclusion Criteria:

* Eligible patients are adults with COVID-19 confirmed by a positive PCR (Polymerase Chain Reaction) test and without symptoms

Exclusion Criteria:

* any patient hypersensitive to hydroxychloroquine or under traditional herbal treatment in the two weeks preceding inclusion,
* any patient with other acute or chronic illnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral treatment;
* any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion.
* pregnant women,
* severe neurological manifestations

Primary outcomes:
measure: Virologic clearance of throat swabs or lower respiratory tract secretions
timeFrame: day 3 to day 14
Secondary outcomes:
measure: COVID-19 symptoms development
timeFrame: day 1 to day 14
measure: Adverse effects
timeFrame: day 1 to day 14
measure: Worsened condition
timeFrame: day 1 to day 14
Other outcomes:
Locations:
city: Conakry
country: Guinea
facility: Support Centers of Donka, Kenien and Gbessia
Study officials:
affiliation: Infectious Disease Department - Donka National Hospital Conakry Guinea
name: Saliou Sow
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculté des Sciences et Techniques de Santé, Université GAN Conakry
name: Mohamed Cissé
role: STUDY_CHAIR
affiliation: Institute for Research and Development of Medicinal and Food Plants of Guinea
name: Mamadou A Baldé
role: STUDY_DIRECTOR
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