Status of DNDi clinical trials during the COVID-19 pandemic

Status of DNDi clinical trials during the COVID-19 pandemic

While exploring how DNDcan lend support, capacity, assets, and expertise in support of the COVID-19 response in resource-constrained settings, our top priority is to ensure the health, safety, and well-being of the people currently enrolled in our clinical trials, and of our staff and partners. Many of the people participating in clinical studies have serious illnesses, some life-threatening, for which they are receiving treatment. DNDi has a duty of care to continue their treatment during this time while ensuring their safety, maintaining compliance with good clinical practice and safety reporting obligations, and maintaining trial data integrity.

DNDi has established a Clinical Trials Task Force to evaluate the safety and feasibility of the conduct of our ongoing clinical trials, discuss the status of our studies and make recommendations to the senior executive regarding any necessary changes. The Clinical Trials Task Force is taking into consideration recently issued guidance from the World Health Organization, European Medicines Agency, and the U.S. Food and Drugs Administration, as well as national and local guidance.

The table below provides a summary of the status and any changes to planned and ongoing clinical trials. It will be updated as needed.

Last updated: 12 October 2021

Study protocols in preparation

StudyDiseaseCountryStatus
No study for the moment

Study protocol approved but no patient yet enrolled

StudyDiseaseCountryStatus
DNDi-5FC-01-CMCryptococcal meningitisSouth AfricaStudy is expected to start in July 2021.
DNDi-5FC-02-CMCryptococcal meningitisSouth AfricaRecruitment expected to start in the first quarter of 2022.
DNDi-EMO-04

(Phase II)
River blindnessGhanaRecruitment is expected to start in August 2021.
DNDi-OXA-04-HAT

(Phase II/III, HAT-seropositives study)
Sleeping sicknessDemocratic Republic of CongoProtocol of the trial is in preparation, recruitment has not started yet.
DNDi-OXA-05-HAT

(Phase IIIb, “Acozi-kids” study)
Sleeping sicknessDemocratic Republic of Congo, GuineaProtocol of the trial is in preparation, recruitment has not started yet. First patient first visit is planned in September 2021.

Phase I studies with healthy volunteers

StudyDiseaseCountryStatus
DNDi-6148-01

(Phase I, multiple ascending dose)
LeishmaniasisFranceStudy is completed.
DNDi-0690-02

(Phase I, multiple ascending dose)
Visceral leishmaniasisUKRecruitment has resumed. Dosing is in progress.

Study protocol approved and patient enrolment ongoing as of March 2020

StudyDiseaseCountryStatus
DNDi-MILT-08-CL

(Phase III)
Cutaneous leishmaniasisBrazil, Bolivia, Panama, PeruPatients enrolment started in Panama, preparatory work continues for the other sites.
DNDi-FEX-07-HAT

(Phase II/III)
Sleeping sicknessMalawi, Uganda40 patients were treated, 12 patients are in ongoing follow-up visits.
DNDi-TYL-01

(Phase II)
River blindnessDemocratic Republic of CongoRecruitment started in one site and is expected to start in August 2021 for the second site.
NuestroBen-2020

(Phase III)
Chagas diseaseArgentinaPatients recruitment started in one out of the six sites.

Study protocol approved and patient enrolment completed – follow-up phase

StudyDiseaseCountryStatus
DNDi/SOF/RDV-01-HCV

(“STORM-C” study)
Hepatitis CMalaysia, ThailandFollow-up visits are completed.
DNDi-MILT/PM-01-VL

(Phase III)
Visceral leishmaniasisEthiopia, Kenya, Sudan, UgandaFollow-up visits are completed. Close out visits will be conducted between July and August 2021.
DNDi-FOSR-04-MYC

(Phase II)
MycetomaSudanAll patients have now completed follow-up. Database analysis expected to start by end August 2021.

COVID-19

We are working to coordinate clinical trials, facilitate and accelerate research, and advocate for accountability.