COVID 19
Conditions
Interventions
PARACETAMOL
Lopinavir Ritonavir ARM STOPPED
Hydroxychloroquine ARM STOPPED
Nitazoxanide and Ciclesonide
Ivermectin and Amodiaquine Artesunate
Fluoxetine and Budesonide
Sponsors
Drug for Neglected Diseases initiative
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 2. Adults > or= 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology or validated antigenic test available in the country for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening. 4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) > or= 94%. 5. Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 6. Signed written consent from the patient or his/her representative. 7. Accepting and having the ability to be reached by telephone throughout the study. 8. Having designated a contact person who can be contacted in case of emergency.
Exclusion criteria
Exclusion criteria: 1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute; • blood pressure 160/100 mmHg; • body weight or= 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis; • recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia ( 40 mg daily; • immunosuppressive treatment; 15. For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use. 16. Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g. no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber. 17. Any other reason that makes it impossible to monitor the patient during the study. 18. Enrolled in other clinical trials with unregistered drugs or with registered drug which could interact with any of the study IPs or contra-indicated as concomitant treatment within the past 3 months prior screening. 19. Known pulmonary arterial hypertension (PAH) or fibrosis. 20. Use of concomitant medications that are contraindicated with ciclesonide, known hypersensitivity to ciclesonide or any other ingredient in the formulation. 21........
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •SpO2 < or equal to 93% on repeated measurement within 21 days after randomisation of treatment, which will be considered as failure. Death for any reasons occurring within 21 days after randomisation of treatment will be considered as failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Mean number and incidence rate of serious adverse events (SAEs) • Mean number and incidence rate of severe adverse events • Mean number of discontinuations or temporary suspensions of IP ;• Number of hospitalisations due to severe progression;• Time to hospitalisation;• Disease-free status: disease-free based on normalisation of pre-existing symptoms (based on mMRC scale, scale of Clinical progression and clinical symptoms) and SpO2 > or equal to 94 at Day 21 and no hospitalisation for COVID-19 ;• Occurrence of death related to COVID-19;• Time to worsening of SpO2 < or equal to 93 within 21 days;• Failure rate for each study arm (see Primary Endpoint);• Occurrence of SpO2 < 93 or death or hospitalisation due to COVID-19;• Sub-group analysis of failure rate for each study arm | — |
Countries
Burkina Faso, Cameroon, Cote Divoire, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mozambique, Sudan, Tanzania, Uganda
Contacts
Public ContactJames Arkinstall
Head of Communications and Advocacy
Outcome results
None listed