Clinical trials: Clinical Infection
COVID-19
Clinical Study of F61 Injection in Healthy Chinese Subjects
Main purpose: To evaluate the safety and tolerability of single-dose ascending intravenous infusion of F61 in healthy subjects. Secondary purpose: To evaluate the pharmacokinetic profile and immunogenicity of F61 administered by…
- Trial name
- NCT05483504
- Testing
- F61 injection
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Wuhan Institute of Biological Products Co., Ltd
Viral Respiratory Tract Infection
Safety and Tolerability of Single and Multiple Doses of Neumifil
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of…
- Trial name
- NCT05093530
- Testing
- Neumifil
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pneumagen Ltd.
Infection, Human Immunodeficiency Virus
Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects
Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration of a combination of antiretroviral drugs to reduce the patient's HIV levels.
- Trial name
- NCT02373930
- Testing
- DTG 50 mg, RPV 25 mg, DTG/RPV 50 mg/25 mg: Product Code AS
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Systemic Infection
Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray CSI reagent pouch.
- Trial name
- NCT03064100
- Testing
- Observational Study
- Where
- 3 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- BioFire Diagnostics, LLC
Measles, Mumps
Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with…
- Conditions
- Measles, Mumps, Rubella, Varicella
- Trial name
- NCT00092430
- Testing
- V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypogammaglobulinemia, Bacterial Infections
A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in…
- Conditions
- Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma
- Trial name
- EXCELL (NCT05645107)
- Testing
- Xembify
- Where
- 62 sites in United States, Bosnia and Herzegovina and 6 more
- Volunteers
- 386 people
- Sponsor
- Grifols Therapeutics LLC
Sepsis, Shock, Septic
Sepsis Assessment in Belgian Emergency Rooms
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.
- Conditions
- Sepsis, Shock, Septic, Severe Sepsis
- Trial name
- SABER (NCT02424721)
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Axis Shield Diagnostics Ltd
Carcinoma, Merkel Cell
Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)
This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).
- Trial name
- NCT02155647
- Testing
- Avelumab
- Where
- 61 sites in United States, Australia and 5 more
- Volunteers
- 204 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Covid19
Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy…
- Trial name
- COSMIC (NCT05280717)
- Testing
- sotrovimab
- Where
- 10 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Gastroenteritis, Infectious Colitis
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.
- Trial name
- NCT02497417
- Where
- 4 sites in United States
- Volunteers
- 1,021 people
- Sponsor
- Luminex Corporation
Hepatitis C, Chronic
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic…
- Trial name
- NCT02765490
- Testing
- AL-335, Odalasvir, Simeprevir
- Where
- 28 sites in Belgium, Canada and 4 more
- Volunteers
- 365 people
- Sponsor
- Janssen Research & Development, LLC
Fungal Infection
ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia
Due to the poor outcome of patients with invasive fungal infections (IFI), a more effective prevention of these infections in such patients is wanted.
- Trial name
- NCT00386997
- Testing
- liposomal amphotericin B (AmBisome®)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Gilead Sciences
Tinea Pedis
Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis
The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with…
- Trial name
- NCT00804193
- Testing
- Ciclopirox Olamine Topical Suspension, Ciclopirox Topical Suspension 0.77%-Reference Product
- Volunteers
- 553 people
- Sponsor
- Padagis LLC
Measles, Varicella
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.
- Conditions
- Measles, Varicella, Mumps, Rubella
- Trial name
- NCT00751348
- Testing
- PriorixTM, VarilrixTM, Priorix-Tetra®
- Where
- 13 sites in South Korea
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis…
- Trial name
- ASTRAL-1 (NCT02201940)
- Testing
- SOF/VEL
- Where
- 80 sites in United States, Belgium and 7 more
- Volunteers
- 741 people
- Sponsor
- Gilead Sciences
COVID-19
Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada
This study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to <55 and 65 to <85 years of age,with the randomized, observer-blind…
- Trial name
- NCT04398147
- Testing
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
- Where
- Canada
- Volunteers
- 696 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Chronic HDV Infection
A Clinical Study of HH-1270 in Healthy Chinese Subjects
This study is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial to evaluate the safety and PK profile in healthy Chinese subjects.
- Trial name
- NCT07876440
- Testing
- HH-1270
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Huahui Health
HIV-1 Infection
Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).
- Trial name
- NCT07841990
- Testing
- B/F/TAF, GS-3242, Lenacapavir
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Gilead Sciences
SARS-CoV-2 Infection
Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection
This is a Prospective, Randomized, Multi-center, Open label, Phase 1/2 study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum [F(ab')2].
- Trial name
- PROTECT (NCT04834908)
- Testing
- Equine COVID-19 Antiserum, Standard of care
- Where
- India
- Volunteers
- 7 people
- Sponsor
- Bharat Serums and Vaccines Limited
Measles, Measles-Mumps-Rubella+Chickenpox Vaccine
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age
This study is evaluating the immunogenicity and safety of intramuscular administration of the investigational MMRVNS vaccine compared to intramuscular administration of the MMRV (Merck's measles, mumps, rubella and varicella)…
- Trial name
- NCT07406360
- Testing
- MMRVNS, MMRV
- Where
- 17 sites in United States
- Volunteers
- 1,209 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline