Infectious Disease clinical trial failures

Phase I Malaria trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: REGULATORY.

The study remains on hold due to a funding issue after it's been lifted by the FDA.

Phase III COVID trial by University of Minnesota. Stop reason: EFFICACY/FUTILITY.

Stopped for futility - no safety issues.

Phase II RSV Infection trial by Gilead Sciences. Stop reason: OPERATIONAL.

Study was terminated by Sponsor; the decision was not due to any safety findings.

Phase III Surgical Site Infection trial by PolyPid Ltd.. Stop reason: OPERATIONAL.

company prioritization reasons

Phase II Covid19 trial by HonorHealth Research Institute. Stop reason: OPERATIONAL.

Closed due to poor enrollment

Phase I Coronavirus trial by Celularity Incorporated. Stop reason: OPERATIONAL.

Lack of enrollment due to COVID treatment options availability.

Phase II Covid19 trial by PureTech. Stop reason: OTHER/UNKNOWN.

Part A of the study was completed; Part B of the study was terminated

Phase IV Surgical Site Infection trial by The University of Texas Medical Branch, Galveston. Stop reason: EFFICACY/FUTILITY.

Futility

Phase II Respiratory Syncytial Virus Infections trial by Shanghai Ark Biopharmaceutical Co., Ltd.. Stop reason: OPERATIONAL.

The study was terminated early due to COVID-19-related enrollment disruptions, not as a result of any product safety concerns.

Phase II Chronic Fatigue Syndrome trial by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland. Stop reason: OTHER/UNKNOWN.

occurrence of scientific risk

Phase III COVID-19 trial by University Hospital, Tours. Stop reason: OTHER/UNKNOWN.

COMPETITOR TEST (RECOVERY)

Phase III Influenza trial by BioCryst Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II COVID-19 trial by Aptabio Therapeutics, Inc.. Stop reason: OPERATIONAL.

Enrollment Challenges

Phase III HIV-1-infection trial by ANRS, Emerging Infectious Diseases. Stop reason: OPERATIONAL.

Low recruitment rate

Phase II RSV Infection trial by Gilead Sciences. Stop reason: OPERATIONAL.

Study was terminated by Sponsor; the decision was not due to any safety findings.

Phase II COVID-19 trial by University of Chicago. Stop reason: OPERATIONAL.

Lack of recruitment of patients into the trial

Phase IV HIV-1-infection trial by Trieu, Nguyen Thi, M.D.. Stop reason: OPERATIONAL.

The study was withdrawn before enrollment due to administrative and board approval constraints.

Phase III COVID-19 trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

The study was terminated as per Sponsor decision

Phase II Tuberculosis, Pulmonary trial by Fundació Institut Germans Trias i Pujol. Stop reason: OPERATIONAL.

The impact of the COVID-19 pandemic on TB diagnosis affected greatly the recruitment rate and posed challenges to the trial's timeline, consuming the funding needed to continue the enrolment.

Phase III Influenza trial by BioCryst Pharmaceuticals. Stop reason: OPERATIONAL.

This study was withdrawn for administrative reasons. The dose ranging plan for the program was revised".

Phase IV Hiv trial by Chelsea and Westminster NHS Foundation Trust. Stop reason: OPERATIONAL.

The CI, sponsor and funder jointly made the decision to end the trial due to lack of recruitment, as well as due to delays it was felt value of the primary endpoint had lessened to a point where its scientific value was questioned.

Phase I Adenovirus trial by Jessie L. Alexander, MD. Stop reason: OTHER/UNKNOWN.

Sponsor Investigator Moved To Stanford

Phase I Acute Respiratory Distress Syndrome trial by Brigham and Women's Hospital. Stop reason: OPERATIONAL.

Due to low enrollment, the study was halted early.

Phase III Diarrhea Travelers trial by Centers for Disease Control and Prevention. Stop reason: OTHER/UNKNOWN.

Unable to reach target sample size.

Phase II Pneumonia With Hospitalized Elderly Patient trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

target number of inclusion not reached

Phase II Chronic Lymphocytic Leukemia trial by City of Hope Medical Center. Stop reason: OTHER/UNKNOWN.

Resources

Phase II Pulmonary Tuberculosis trial by Gates Medical Research Institute. Stop reason: OTHER/UNKNOWN.

Data generated in the Gates MRI-TBD06-201 trial do not support the investigational regimens being able to achieve the trial objective of identifying a new regimen to treat tuberculosis in 3 months or less.

Phase II COVID-19 trial by Inmune Bio, Inc.. Stop reason: EFFICACY/FUTILITY.

Futility

Phase IV HIV Lipodystrophy Syndrome trial by Columbia University. Stop reason: OTHER/UNKNOWN.

lack of availability of the study drug

Phase IV COVID-19 trial by Nicholas Carlson. Stop reason: OPERATIONAL.

No funding

Phase III SARS-CoV 2 trial by APR Applied Pharma Research s.a.. Stop reason: OPERATIONAL.

Sponsor decision

Phase III Coronavirus trial by Biocon Limited. Stop reason: OTHER/UNKNOWN.

Sponsor has currently elected to withhold study initiation

Phase II Bronchiolitis, Viral trial by University of Louisville. Stop reason: OPERATIONAL.

unable to enroll any subjects

Phase III Community-Acquired Pneumonia (CAP) trial by ImmunityBio, Inc.. Stop reason: OTHER/UNKNOWN.

New protocol developed

Phase III COVID-19 trial by South African National Blood Service. Stop reason: EFFICACY/FUTILITY.

No benefit seen in 2 published inpatient RCTs (but had limitations). Press release from inpatient Recovery trial with large number of endpoints showed no benefit. CCP collected from survivors of original strain infection had no neutralisation

Phase III HIV Preexposure Prophylaxis trial by Merck Sharp & Dohme LLC. Stop reason: SAFETY.

Voluntarily terminated due to benefit/risk assessment.

Phase II Post-COVID-19 Syndrome trial by Charite University, Berlin, Germany. Stop reason: SAFETY.

Following a recommendation from the Data Safety Monitoring Board (DSMB).

Phase I Shingles trial by Pfizer. Stop reason: OPERATIONAL.

Strategic decision made by the company

Phase II Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trial by M.D. Anderson Cancer Center. Stop reason: OTHER/UNKNOWN.

\<75% participation

Unknown Hiv trial by Brigham and Women's Hospital. Stop reason: OPERATIONAL.

Study withdrawn prior to enrollment due to lack of funding.

Phase I HIV trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

The HVTN 303 IND was placed on clinical hold, and recruitment did not resume.

Phase II HIV-1-infection trial by Gilead Sciences. Stop reason: OPERATIONAL.

Sponsor decision to terminate study.

Phase III Post-COVID Postural Orthostatic Tachycardia Syndrome trial by CSL Behring. Stop reason: OPERATIONAL.

Sponsor decision, not for safety reasons.

Phase II Malaria trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OTHER/UNKNOWN.

After careful review of R21 interaction data that recently became available from a previous L9LS infant study, the study team has made the decision to not move forward with this protocol.

Phase II HIV I Infection trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

Trial terminated by Sponsor.

Phase II Opioid-use Disorder trial by University of Pennsylvania. Stop reason: OPERATIONAL.

Funding not renewed

Phase III HBe Negative Chronic Hepatitis B trial by French National Agency for Research on AIDS and Viral Hepatitis. Stop reason: OTHER/UNKNOWN.

safety aspects

Phase II HIV Infection Associated Kaposi Disease trial by French National Agency for Research on AIDS and Viral Hepatitis. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III COVID-19 trial by Universidad de Antioquia. Stop reason: OTHER/UNKNOWN.

Study was stopped because Principal Investigator did not obtain sponsorship to carry it out

Phase I Parainfluenza trial by St. Jude Children's Research Hospital. Stop reason: OPERATIONAL.

voluntary Hold because of COVID-19, all participants were off study prior to the hold.

Phase III COVID-19 trial by University of Maryland, Baltimore. Stop reason: OPERATIONAL.

The Principal Investigator left the institution. The study was halted prematurely.

Phase II Coronavirus Infections trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

COVID wave passed

Phase II Coronavirus Infections trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

COVID wave passed and we closed the study prematurely

Phase II Filovirus Disease trial by Gilead Sciences. Stop reason: OPERATIONAL.

The study was withdrawn after the Marburg outbreak in Rwanda was declared over, prior to enrollment of any participants.

Phase I Ebola Virus Disease trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

Cancel Enrollment due to Covid-19 Pandemic, Not restarted

Phase II Pneumonia trial by CalciMedica, Inc.. Stop reason: OPERATIONAL.

The trial was terminated early due to the limited number of new COVID-19 hospitalizations.

Unknown Severe/Moderate Coronavirus trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OTHER/UNKNOWN.

Abandonment of the study project

Phase II Gram-negative Bacteremia trial by University Health Network, Toronto. Stop reason: OTHER/UNKNOWN.

Study intervention not available. Manufacturer no longer producing MET-2.

Phase I HIV Infections trial by PENTA Foundation. Stop reason: OTHER/UNKNOWN.

Study not started as the IMP is re-worked by the manufacturer

Phase II Cytomegalovirus Anterior Uveitis trial by University of California, San Francisco. Stop reason: OPERATIONAL.

Funding discontinued.

Phase I HIV-1 trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OTHER/UNKNOWN.

Temporarily Closed (paused)

Phase II COVID-19 trial by Heron Therapeutics. Stop reason: OTHER/UNKNOWN.

Study was terminated early by Heron, and was not terminated for safety reasons.

Phase IV Urinary Tract Infections trial by University of Texas Southwestern Medical Center. Stop reason: OTHER/UNKNOWN.

Because the study investigator is no longer following these patients as part of this study. They are followed as part of SOC as the study investigator's patients.

Phase III Infectious Pneumonia trial by Dompé Farmaceutici S.p.A. Stop reason: EFFICACY/FUTILITY.

The study was stopped due to futility as per protocol

Phase IV Benign Prostatic Hyperplasia trial by Baylor Research Institute. Stop reason: OPERATIONAL.

Lack of enrollment.

Unknown Periprosthetic Joint Infection trial by University of Maryland, Baltimore. Stop reason: OPERATIONAL.

No participants enrolled.

Phase II Covid19 trial by University of Minnesota. Stop reason: OTHER/UNKNOWN.

Duplicate record to NCT04115514

Phase III COVID-19 trial by Queen's Medical Center. Stop reason: OTHER/UNKNOWN.

Per Queen's Regulatory Office, study is terminated or expired.

Phase III COVID-19 trial by Queen's Medical Center. Stop reason: EFFICACY/FUTILITY.

RECOVERY Trial results - no efficacy

Phase III HIV-I trial by Merck Sharp & Dohme LLC. Stop reason: SAFETY.

Voluntarily terminated due to benefit/risk assessment

Phase II COVID-19 trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.

Phase II Alexithymia trial by University of California, San Diego. Stop reason: OPERATIONAL.

Original funding period ended and a no-cost extension was not granted. Without funding to continue, the study was stopped.

Phase I Pneumonia, Interstitial trial by Baylor Research Institute. Stop reason: OPERATIONAL.

Funding was not obtained and study was not activated

Phase II COVID-19 trial by Johns Hopkins University. Stop reason: OPERATIONAL.

The study was terminated due to insufficient participant enrollment resulting from a lower-than-expected number of COVID-19 cases

Phase III Tuberculosis Infection trial by Henry M. Jackson Foundation for the Advancement of Military Medicine. Stop reason: OPERATIONAL.

The sponsor has elected to discontinue/terminate the study prematurely due to slower-than-anticipated recruitment and limited remaining research funding.

Phase IV Pneumonia trial by Weill Medical College of Cornell University. Stop reason: OPERATIONAL.

Due to slow accrual.

Phase IV Ventilator Associated Pneumonia trial by University of Miami. Stop reason: OPERATIONAL.

The rate of enrollment was slower than expected

Early Phase I Malaria, Vivax trial by University of Oxford. Stop reason: OPERATIONAL.

The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.

Phase II HIV1 Infection trial by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba. Stop reason: EFFICACY/FUTILITY.

No response regarding coverage of treatments by social security and the DGOS

Phase II Plasmodium Falciparum Malaria trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor decision

Phase I Hematopoietic and Lymphoid Cell Neoplasm trial by Roswell Park Cancer Institute. Stop reason: OPERATIONAL.

Low accrual

Phase II Community-acquired Pneumonia trial by Senhwa Biosciences, Inc.. Stop reason: OPERATIONAL.

The trial ended early in March 2025 due to changes in disease epidemiology, affecting patient availability and recruitment feasibility.

Phase III Chikungunya Virus Infection trial by Valneva Austria GmbH. Stop reason: REGULATORY.

No participant recruited; trial initiation postponed to an unspecified future time while Valneva assesses potential pathways to address regulatory requests. Evaluation is ongoing to ensure alignment with regulatory expectations and obligations.

Phase I Respiratory Syncytial Virus Infections trial by Pfizer. Stop reason: OPERATIONAL.

Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study

Phase IV Aspiration trial by UConn Health. Stop reason: OPERATIONAL.

Under-enrollment

Phase I COVID-19 trial by Baylx Inc.. Stop reason: OPERATIONAL.

It is a strategic decision by the company, coupled with low incidence of ARDS cases following widespread vaccination efforts.

Phase III Influenza trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

The study was interrupted due to COVID-19 pandemic and terminated due to new changes to the recommendations for flu vaccines

Phase I Severe Acute Respiratory Syndrome trial by Henry Ford Health System. Stop reason: OPERATIONAL.

No participants due to waning pandemic.

Phase I Ebola Virus Disease trial by University of Oxford. Stop reason: OTHER/UNKNOWN.

Long term follow up will take place in a new clinical trial.

Phase I Tuberculosis trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

Study not implemented due to funding.

Phase III Covid19 trial by Eli Lilly and Company. Stop reason: OTHER/UNKNOWN.

Study terminated due to an inability to enroll participants.

Phase II Covid19 trial by Darcy Spicer. Stop reason: OPERATIONAL.

Futile Enrollment

Phase III Cytomegalovirus Infection trial by ModernaTX, Inc.. Stop reason: EFFICACY/FUTILITY.

The Sponsor decided to terminate the study after it did not meet the primary efficacy endpoint at final analysis. The safety profile was consistent with prior studies, and no safety concerns were raised by the Data and Safety Monitoring Board.

Phase I Pneumonia trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

Lack of funding

Phase II Bone or Joint Infection trial by Debiopharm International SA. Stop reason: OPERATIONAL.

This trial was concluded for strategic reasons.

Phase II SARS-CoV-2 trial by ModernaTX, Inc.. Stop reason: OTHER/UNKNOWN.

The trial was terminated because data from the dose finding part of the trial did not support further evaluation of effectiveness of mRNA-1273. There were no safety concerns.

Phase II COVID-19 trial by Abivax S.A.. Stop reason: EFFICACY/FUTILITY.

Interim analysis concludes that the study is futile

Phase I Human Immunodeficiency Virus (HIV) Infection trial by Hookipa Biotech GmbH. Stop reason: OPERATIONAL.

business decision

Phase II Recurrent Clostridioides Difficile Infection trial by Recursion Pharmaceuticals Inc.. Stop reason: OPERATIONAL.

Study was terminated due to sponsor decision. This decision was not related to safety concerns.

Phase III COVID-19 trial by University of Minnesota. Stop reason: EFFICACY/FUTILITY.

DSMB closed due to futility.