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Trial - NCT04715295


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

Eugene Sobngwi, MD, PhD

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"}]