COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12150

James Arkinstall

media@dndi.org

2020-06-15

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

1. Abnormal physical examination findings: • respiratory rate > or= 25 per minute, • blood pressure < 90/60 mmHg or > 160/100 mmHg, • body weight < 45 kg for patients > 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 (< 3.5 mmol/L). 2 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 3. Feeling unwell for more than 7 days prior to screening. 4 to 7 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months. 9.-13 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms 14. On-going treatment at screening with: • chronic systemic glucocorticosteroid > 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........

6

Drug for Neglected Diseases initiative

12

100

Burkina Faso;Cameroon;Equatorial Guinea;Ethiopia;Ghana;Kenya;Mozambique;Congo;Sudan;Uganda;United Republic Of Tanzania

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

3000

• 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.

| Declared number of arm (6.0) differs from found arms (7.0)

Phase 3

[{"arm_notes": "", "treatment_id": 958, "treatment_name": "Paracetamol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1650, "treatment_name": "Ciclesonide+nitazoxanide", "treatment_type": "Corticosteroids+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2366, "treatment_name": "Artesunate-amodiaquine+ivermectin", "treatment_type": "Antimalarials+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2515, "treatment_name": "Budesonide+fluoxetine", "treatment_type": "Corticosteroids+central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}]