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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502342
Recruitment Status : Enrolling by invitation
First Posted : August 6, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Institute for Research and Development of Medicinal and Food Plants of Guinea

Brief 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.


Condition or disease Intervention/treatment Phase
Covid19 Combination Product: Hydroxycloroquine and Azythromycine Combination Product: Cospherunate/Azythromycine Combination Product: Cospherunate/Phytomedicine/Azythromycien Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible consenting symptomatic 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 and the onset of COVID symptoms are evaluated throughout the trial period. Clinical, paraclinical and laboratory examinations are occasionally provided. The data are statiscally processed.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Évaluationefficacité et tolérance d'Une médication à Base de Cosphérunate et d'un phytomédicament Antiviral Par Voie Orale en Comparaison Avec un Traitement à Base d'Hydroxychloroquine Chez Des Adultes Malades Covid-19 Sans Complications
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Active Comparator: Hydroxychloroquine/Azythromycin
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
dual treatment with Hydroxycloroquine and Azythromycine

Experimental: Cospherunate/Azithromycine
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
dual treatment with Cospherunate and Azythromycine

Experimental: Cospherunate/Phytomedicine/Azithromycine
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
triple treatment with Cospherunate, Asen and Azythromycine
Other Name: Cospherunate/Asen/Azythromycine




Primary Outcome Measures :
  1. Virological clearance of throat swabs or lower respiratory tract secretions [ Time Frame: day 3 to day 14 ]
    Virological clearance from admission to discharge at days 3, 6 and 14


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: day 1 to day 14 ]
    number of patients who developed treatment-related adverse effects

  2. Worsened conditions [ Time Frame: day 1 to day 14 ]
    number of patients whose conditions worsened

  3. COVID-19 symptoms [ Time Frame: day 1 to day 14 ]
    number of patients whose fever, cough and any other clinical sign observed on introduction have resolved



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502342


Locations
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Guinea
Donka; Kenien; Gbessia
Conakry, Guinea, 224 Conakry
Sponsors and Collaborators
Institute for Research and Development of Medicinal and Food Plants of Guinea
Investigators
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Study Director: Mamadou A Baldé RDIMFPG
Publications of Results:
• WHO | World Health Organization. Coronavirus (COVID-19) events as they happen [Internet]. 2020 [cited 2020 Mar 20]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen

Other Publications:

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Responsible Party: Institute for Research and Development of Medicinal and Food Plants of Guinea
ClinicalTrials.gov Identifier: NCT04502342    
Other Study ID Numbers: RDIMFPG
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The data could be available from september 30th to december 30th
Access Criteria: partnership framework established

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute for Research and Development of Medicinal and Food Plants of Guinea:
Treatment; clinical research
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases