Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715295
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2020-10-02
Brief Title:
Safety and Efficacy of Doxycycline and Rivaroxaban in COVID-19
Sponsor:
Yaounde Central Hospital
Organization:
Yaounde Central Hospital
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 ie 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 conditionsco-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 ie 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 conditionsco-morbidities and by age group
Study Oversight
Has Oversight DMC:
None
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?:
None