A Phase 2 interventional study of Hydroxycloroquine and Azythromycine and Cospherunate/Azythromycine in Covid19, sponsored by Institute for Research and Development of Medicinal and Food Plants of Guinea. Status unknown at 1 site in Guinea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Institute for Research and Development of Medicinal and Food Plants of Guinea · Phase 2, Interventional, and Treatment
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 30 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Institute for Research and Development of Medicinal and Food Plants of Guinea is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received Hydroxychloroquine 200 mg tablet orally 3 times daily for 10 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days.
Combination Product: Hydroxycloroquine and Azythromycine
Patients received Cospherunate (50 mg Artésunate/125 mg Amodiaquine) at the rate of 2 tablets orally twice daily for 6 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days.
Combination Product: Cospherunate/Azythromycine
Patients received Cospherunate (50 mg Artésunate/125 mg Amodiaquine) at the rate of 2 tablets orally twice daily for 6 days and Phytomedicine tablet 350 mg at the rate of 2 tablets orally twice daily for 6 days, and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days.
Combination Product: Cospherunate/Phytomedicine/Azythromycien
dual treatment with Hydroxycloroquine and Azythromycine
dual treatment with Cospherunate and Azythromycine
triple treatment with Cospherunate, Asen and Azythromycine
Also known as: Cospherunate/Asen/Azythromycine
Virological clearance of throat swabs or lower respiratory tract secretions
Virological clearance from admission to discharge at days 3, 6 and 14
Time frame: day 3 to day 14
Adverse effects
number of patients who developed treatment-related adverse effects
Time frame: day 1 to day 14
Worsened conditions
number of patients whose conditions worsened
Time frame: day 1 to day 14
COVID-19 symptoms
number of patients whose fever, cough and any other clinical sign observed on introduction have resolved
Time frame: day 1 to day 14
Plan to share: Yes — The samples stored in the biobank could be shared with other researchers with a view to in-depth analyzes in order to dig for example a posteriori on the hypotheses relating to the blood levels of the phytomedicine, hydroxychloroquine, etc., cardio-metabolic biological markers infarction, insulin sensitivity, thrombosis, specific antibodies, genetic markers, viral markers ...
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: The data could be available from september 30th to december 30th
Access criteria: partnership framework established
Started Jun 2020 (actual). Primary completion is estimated for Aug 2020, 2 months after the start.
Of 359 non-industry phase 2 interventional studies under COVID-19, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 2 months is below that.
Counting every sponsor, half of 582 studies reached it within 9 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Institute for Research and Development of Medicinal and Food Plants of Guinea