Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 11:52 PM
Study NCT ID:
NCT04715295
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19
Sponsor:
Yaounde Central Hospital
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOXYCOV
Brief 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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: