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.
The patient who has signed the informed consent for participation in the study will be
immediately taken care of by the investigating clinicians. The clinician will determine the
history of the disease and identify any clinical signs shown by the patient. Clinical data
will be recorded in the patient's medical file. At the end of the clinical examination, the
investigating clinician will draw up the report of the biological examinations.
Laboratory examinations will be carried out according to the procedures and method by
accredited laboratories in Guinea (National Institute of Public Health; Hemorrhagic Fevers
Laboratory; CREMS - Kindia Laboratory; Institut Pasteur de Guinée) for the diagnosis of
COVID19.
After inclusion, patients are assigned by randomization into separate treatment arms with 10
patients per arm. They remain in these treatment arms for the duration of the trial,
analysis, and follow-up activities. A random sequence will be generated and implemented so as
to randomize.
The treatments will be made available to investigative clinicians by the Institute for
Research and Development of Medicinal and Food Plants of Guinea.
All subjects meeting 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. The data will be coded, entered and processed using statistical
software. Data entry quality control will be performed on all files. The selected patients
are distributed randomly into 3 parallel arms, each arm having a different treatment
modality.
A homogeneity test on the main socio-demographic variables (age, sex, weight, hemoglobin
level, etc.) will be carried out between the different treatment arms before any specific
analysis. Baseline characteristics and treatment of subjects in arms 1, 2 and 3 will be
presented as medians, ranges for all parameters such as clinical, anthropometric, biochemical
values and as percentages or numbers for symptoms. The comparison between the three cohorts
will be made using either the Anova test for continuous variables or the chi2 test for
categorical variables.
The rate of change over time of virologic clearance, fever and other symptom values as well
as the differences for these rates between treatment arms will be tested using mixed-effects
modeling.
The duration of the trial is 20 days for each patient recruited. In anticipation of future
analyzes, the biological samples will be kept at the biobank of the National Institute of
Public Health of Guinea.
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
Other Name: Cospherunate/Asen/Azythromycine
Inclusion Criteria:
- eligible patients are symptomatic adults with COVID-19 confirmed by a positive
Polymerase Chain Reaction test without complications
Exclusion Criteria:
- any patient herpersensitive to hydroxychloroquine or under antimalarial treatment in
the 2 weeks preceding inclusion;
- any patient with a complication who must be taken care of in an Emergency or Intensive
Care Unit;
- any patient with other acute or chronic ilnesses such as heart failure, arterial
hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take
the oral the oral treatment;
- any patient for whom one of the treatments under study is contraindicated according to
the doctor's opinion;
- pregant women;
- severe neurological manifestations.
Donka; Kenien; Gbessia
Conakry, Guinea
Mamadou A Baldé, Study Director
RDIMFPG