CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 400 enrolled
Drug / intervention
Ivermectin and Doxycycline +1 moredrug
Likely dose
Ivermectin and Doxycycline 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04523831
NCT04523831Phase 3Completed

A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care

Dhaka Medical College·interventional·Posted Aug 24, 2020·Updated Oct 9, 2020

In Brief

A Phase 3 clinical trial evaluating Ivermectin and Doxycycline and Standard of care for Covid19. Completed, enrolled 400 participants across 1 site.

Detailed Summary

On 31 December 2019, the World Health Organization (WHO) was formally notified about a cluster of cases of pneumonia in Wuhan City, China. On 7 January the responsible virus was isolated and its genome sequence was shared on 12 January. It was named as COVID-19, a novel Coronavirus, SARS-CoV-2. It is a member of the Corona virus family which is RNA enveloped viruses. Very rapidly the virus emerged as pandemic. Now it is dominating the lives of every people of this universe. Management of the COVID-19 relies on mainly supportive care and oxygen supplementation via non-invasive or mechanical ventilation in critical cases. Patients who are critically ill may also require vasopressor support and antibiotics for secondary bacterial infections. There is no vaccine or highly effective antiviral drugs for COVID-19. Currently there is a tremendous effort around the world to develop effective preventive and therapeutic treatment for this disease. World Health Organization has launched a non-blinded clinical trial (SOLIDARITY) to evaluate four candidate treatments (remdesivir, lopinavir/ritonavir, lopinavir/ritonavir/ interferon beta-1a, and chloroquine or hydroxychloroquine) versus standard of care in 18 countries worldwide. RECOVERY trial one of the largest trials to see the efficacy and safety of hydroxychloroquine revealed that they are no clear cut clinical benefit for COVID-19. Other drugs in the SOLIDARTY trial are quite expansive for resource limited countries like Bangladesh. Study Published in the American Journal of Tropical Medicine advocates further research into Ivermectin for COVID-19 Treatment. The spotlight on Ivermectin was brought by Australian researchers from Monash University who demonstrated its efficacy against the SARS-CoV-2 coronavirus in vitro studies. In different study Doxycycline also showed promising results in treatment of COVID 19 infection. It is highly lipophilic antibiotics that are known to chelate zinc component of matrix metalloprotienases (MMP). Corona viruses are known to rely heavily of MMPs for survival, cell infiltration and replication. It also has an anti-inflammatory effect which might be effective in combating cytokine storm of Covid-19 infection. So it have been planned to conduct an experimental clinical trial using combination of ivermectin and doxycycline for treatment of COVID 19 along with the other standard care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesBangladesh
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 24, 2020
Enrollment StartJun 1, 2020
Primary CompletionAug 22, 2020
Study CompletionSep 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.9 years ago

Interventions

Ivermectin and Doxycyclinedrug

Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days

Standard of caredrug

Paracetamol, Vitamin D, Oxygen if indicated, Low molecular weight heparin, dexamethasone if indicated