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Column | Value |
---|---|
Trial registration number | NCT04715295 |
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
sobngwieugene@yahoo.fr |
Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-01-20 |
Recruitment status
Last imported at : Jan. 6, 2023, 8 p.m. Source : ClinicalTrials.gov |
Unknown |
Study design
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - covid-19 infection confirmed by sars-cov2 - rt pcr - as per protocol - able to start the treatment within 24 hours from time of diagnosis - patient with mild symptoms as defined by who, with pao2 > 93% - signed written consent of the patient - accepts and has the ability to be reached by phone during the study duration, plus a designated a contact person who can be contacted in case of emergency |
Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- blood pressure < 90/60mm hg - respiratory rate ≥ 30/min - known cardiac condition - known g6pd deficiency - patients with < 45kg - egfr < 30 ml/min or alt ≥ 3n or body temperature ≥ 38°c or any life-threatening comorbidity - any reason that makes it impossible to monitor the patient during the study period - baseline ecg prior to randomization showing qtc > 500 ms - ongoing treatment other than symptomatic - history of retinopathy - absolute contra-indication to treatment with hydroxychloroquine (known hypersensitivity, concomitant treatment at risk of torsades de pointes) - contraindication to any study medication including allergy - ongoing treatment with high dose systemic chronic corticosteroid (> 40 mg) - patients treated by immunosuppressants treatment at the time of randomization - known pregnant women and breastfeeding women |
Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Yaounde Central Hospital |
Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Cameroon |
Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
200 |
primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Clinical;Virological |
Notes
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 4 |
Arms
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1489, "treatment_name": "Doxycycline+rivaroxaban", "treatment_type": "Antibiotics+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |