Status of DNDi clinical trials during the COVID-19 pandemic

While exploring how DNDi can 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 update: 1 April 2020

 

Swipe left to see more

Study

Disease

Country

Status

Study protocol approved but no patient yet enrolled

DNDi-MILT-08-CL

(Phase III)

Cutaneous leishmaniasis

Brazil, Bolivia, Panama, Peru

Preparatory work will continue. Patient enrolment, originally planned for Oct. 2020, will be re-evaluated as actions progress.

 

Study protocols in preparation

DNDi-OXA-04-HAT

(Phase II/III, HAT-seropositives study)

Sleeping sickness

 

Preparation of these trials will continue as far as possible. Study start dates will be re-evaluated as actions progress.

DNDi-OXA-05-HAT

(Phase IIIb, “Acozi-kids” study)

Sleeping sickness

 

DNDi-0690-02

(Phase I, multiple ascending dose)

Visceral leishmaniasis

 

DNDi-EMO-04

(Phase II)

River blindness

 

DNDi-TYL-01

(Phase II)

River blindness

 

DNDi-5FC-01-CM

Cryptococcal meningitis

 

 

Phase I* studies with healthy volunteers

DNDi-6148-01

(Phase I, multiple ascending dose)

Leishmaniaisis

 

Enrolment has been put on hold.

No new Phase 1 trials will be started at this time, according to the recommendation of the Clinical Trials Task Force and approved by the DNDi executive team.

 

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

DNDi-RDV-04-HCV (Bioequivalence, Phase 1)

Hepatitis C

Malaysia

Clinical phase completed. Trial activities to continue to close out as far as possible.

DNDi-PedHIV-002

(“LIVING” study, Phase IIIb)

Paediatric HIV

Kenya, Uganda, Tanzania

Clinical phase completed. Using remote monitoring as much as possible in Kenya. Allowing on-site monitoring in accordance with national guidelines and the epidemiological situation.

DNDi-FEX-09-HAT

(Phase IIIb)

Sleeping sickness

Democratic Republic of Congo, Guinea

Study treatment completed. Follow-up visits are continuing with the situation closely monitored by the teams, according to hospital policies and national guidelines.

DNDi-OXA-02-HAT

(Phase II/III)

Sleeping sickness

Democratic Republic of Congo, Guinea

Study treatment completed. Follow-up visits will continue with the situation closely monitored by the teams, according to SwissTPH (responsible for monitoring), hospital policies, and national guidelines.

DNDi-OXA-03-HAT

(Mass balance, Phase I)

Sleeping sickness

UK

For planned follow-up visits, consulting with the authorities.

DNDi-MILT COMB-01-PKDL

(Phase II)

Post-kala-azar dermal leishmaniasis

Bangladesh, India

All patients have completed treatment and the 12-month follow-up visit. Extended 24-month follow-up visits planned for mid-2020 will go ahead if possible, according to national guidelines and authorities.

 

Study protocol approved and patient enrolment ongoing as of March 2020

DNDi/SOF/RDV-01-HCV

(“STORM-C” study)

Hepatitis C

Malaysia, Thailand

Recruitment of new patients was put on hold on 17 March 2020. Now ensuring treatment continuity and safety assessments of ongoing patients through home-based care and delivery at home of study drugs.

DNDi-4in1-01-PHIV

(“LOLIPOP” study)

Paediatric HIV

Uganda

Trial currently delayed. Plans for moving ahead will first be evaluated by the Clinical Trials Task Force.

DNDi-FEX-07-HAT

(Phase II/III)

Sleeping sickness

Malawi, Uganda

Patient enrolment continues in Malawi and monitoring plans being developed. Study will not start in Uganda for now. Close monitoring of the COVID-19 situation with the relevant authorities.

DNDi-MILT/PM-01-VL

(Phase III)

Visceral leishmaniasis

Ethiopia, Kenya, Sudan, Uganda

Patient enrolment is continuing, with 29 patients remaining to be enrolled in the coming four weeks. For follow-ups, using local monitors when possible. Closely monitoring the COVID-19 situation in countries/sites with the relevant authorities

DNDi-MILT COMB-02-PKDL

(Phase II)

Post-kala-azar dermal leishmaniasis

Sudan

With local investigators, assessing human resources and feasibility to continue patient enrolment. Follow-up visits to continue with close monitoring by the teams, according to hospital and national guidelines.

DNDi-FOSR-04-MYC

(Phase II)

Mycetoma

Sudan

Patient enrolment has been paused pending the arrival of a new shipment of study drugs. Existing supply has been secured for current study participants. Patient follow-ups to continue, according to hospital and national guidelines.