NCT04715295

Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19

Open-label, Randomized Trial of the Safety and Efficacy of Doxycycline and Rivaroxaban Therapy Versus National Standard Therapy in Ambulatory Patients With Mild Symptomatic COVID-19

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Yaounde Central Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg daily on D1 to D7) versus the combination of Hydroxychloroquine (400 mg on D1 to D7) and Azithromycin (500 mg on D1 and 250mg on D2 to D5) as per national standard to treat ambulatory mild COVID-19 patients, with the aim to achieve early negativity of RT-PCR of SARS-CoV-2 from nasopharyngeal swab, and early clinical improvement and prevention of severe disease.

Detailed description

This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg on D1 to D7) versus combination of hydroxychloroquine (400 mg on D1 to D7) and azithromycin (500 mg on D1 and 250mg on D2 to D5) to treat ambulatory patients with mild COVID-19. We aim to demonstrate early improvement of a clinical core set of outcomes and prevention of clinical worsening, and early negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) among ambulatory patients with mild COVID-19 by treating them with Doxycycline and Rivaroxaban compared to patients who receive Hydroxychloroquine and Azithromycin as per National standard therapy of COVid-19. Ambulatory patients with mild symptoms and with confirmed diagnosis of COVID-19 will receive the treatment. The primary objective of the study is to evaluate the Safety and Efficacy of Doxycycline and Rivaroxaban versus National standard therapy of mild COVid-19. The primary endpoint is failure (i.e severe evolution) measured as PaO2 \< 92% within 10 days after initiation of treatment. The secondary objectives of the study are to evaluate * Safety of the different investigational therapies up to D10 days of follow-up per arm, * Hospitalisation due to Covid 19 infection rate per arm, * Time to hospitalisation due to Covid 19 infection, * Cure rate by treatment arm and Death rate, * Worsening as assessed by the need for additional concomitant medication, * Efficacy in sub-groups of patients (with pre-existing conditions/co-morbidities and by age group).

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Doxycycline Tablets	Doxycycline 200 mg daily for 7 days
DRUG	Rivaroxaban 15Mg Tab	Rivaroxaban 15 mg tablets daily from day 1 to day 10
COMBINATION_PRODUCT	Hydroxychloroquine and Azithromycin	Hydroxychloroquine 400mg daily from day 1 to day 5 in combination with Azithromycin 500mg on day 1 and 250 mg daily from day 2 to day 5

Timeline

• Start date: 2020-10-05
• Primary completion: 2021-05-30
• Completion: 2021-09-05
• First posted: 2021-01-20
• Last updated: 2021-01-20

Locations

1 site across 1 country: Cameroon