Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19 — DOXYCOV  

COVID-19 Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04715295
• Study type: Interventional
• Source: Yaounde Central Hospital
• Contact: Eugene Sobngwi, MD, PhD
• Phone: +237675088750
• Email: sobngwieugene@yahoo.fr
• Status: Recruiting
• Phase: Phase 4
• Start date: October 5, 2020
• Completion date: September 5, 2021