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Local tolerability of Cyclops dry powder hydrochloroquine inhalation in healthy volunteers; a pilot study

- Primary objective is to assess the local tolerability of dry powder hydroxychloroquine via the Cyclops* at different dosages.- Secondary objective is to investigate systemic pharmacokinetic parameters of dry powder hydroxychloroquine via the…

A PHASE III, MULTICENTER, RANDOMIZED,
DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY
TO ASSESS THE EFFICACY AND SAFETY OF
BALOXAVIR MARBOXIL IN COMBINATION WITH A
NEURAMINIDASE INHIBITOR VERSUS A
NEURAMINIDASE INHIBITOR ALONE IN
HOSPITALIZED PATIENTS WITH SEVERE
INFLUENZA

This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in…

An open label randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19

To evaluate if treatment with only supportive care or addition of one of two anti-COVID-19 agents (chloroquine or hydroxychloroquine) results in less disease progression in patients with moderate to severe COVID-19 who require hospital admission.

Lanadelumab for treatment of COVID-19 disease

The objectives of this study:• To generate the proof of concept for lanadelumab for treatment of symptoms of COVID-19 disease • To demonstrate its safety after intravenous administration.

A pragmatic adaptive, randomized, controlled phase II/III multicenter study of IFX-1 in patients with severe COVID-19 pneumonia

Primary Objectives:- Phase II: To explore the effect of IFX-1 on COVID-19 related severe pneumonia (hypothesis generating)- Phase III: To demonstrate the efficacy of IFX-1 to improve of symptoms and outcome of severe COVID-19 pneumonia (confirmative…

The effect of medical grade honey (L-Mesitran) for cervical intraepithelial neoplasia-II

The primary aim of this study is to investigate the effect of honey on the clearance of the hr-HPV virus in patients with CIN II.Secondary, the effect of honey on the normalization of CIN lesions, the role of the vaginal microbiome, the local immune…

COBRA re-KAI study: COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after re-vaccination of a kaleidoscopic group of hematological patients: what*s the impact?

To answer the following questions: 1. Who are the patients that need to be revaccinated?2. How many vaccinations are needed to restore SARS-CoV-2 immunity?3. Can the number of vaccinations needed to restore SARS-CoV-2 immunity be predicted?To answer…

A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV coinfection.

The primary objective is to evaluate the proportion of patients with HCV RNA below the level of quantitation (target not detected [TND] or target detected, not quantifiable [TDnq]) at 12 weeks post end of treatment (SVR12) following sofosbuvir/…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications

The primary objective is to evaluate superiority of pimodivir (Pi) in combination with standard-of-care (SOC) treatment (tmt) compared toplacebo in combination with SOC treatment, with respect to the time to resolution of influenza-related symptoms.

Charting of immune reactivity against HPV in patients with HPV-induced (pre-) malignant lesions: The Circle study "2"

The primary objective of this study is to assess presence, number, type, specificity and function of HPV-specific immune response in the peripheral blood, lesions/tumors and their draining lymph nodes of patients at different stages of HPV-induced…

Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders

In the Phase 2 clinical study, the efficacy of the vaccine in non-responders and the safety of the vaccine will be studied.

A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-, NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed (study 201636)

Primary: To demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) over 48 weeks in HIV-1 infected antiretroviral therapy (ART) experienced subjects.…

A Multi-center, Randomized, Open-label study for Induction of HBsAg decline using an add-on treatment of peginterferon alfa-2a in HBeAg-negative chronic hepatitis B patients treated with nucleos(t)ide analogues

To investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with NA enhances the degree of HBsAg decline

Tenofovir toxicity: association with Inosine Triphosphate Pyrophosphohydrolase activity and ITPA genotype

To investigate the association of ITPA genotype and ITPase activity with nephrotoxicity, bone toxicity and recovery of nephrotoxicity and bone toxicity during and after anti-retroviral treatment with a tenofovir containing regimen for HIV.

Bioequivalence study of CRUshed Sofosbuvir/velpAtasvir compareD to the wholE tablet (CRUSADE-1)/Hep-NED004

Primary objective:To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VELSecondary objective:To evaluate the safety and tolerability of crushed SOF/VEL tablets in…

Pharmacokinetics of single-dose dOLutegravir in HIV-serOnegative sub-jects with severe hepatic impairment compared to matched controls (POLO).

The aim of the POLO study is to evaluate pharmacokinetics and safety of a single-dose of dolutegravir in patients with severe hepatic impairment (Child-Pugh score * 10) and compare these to matched controls.

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

Primary ObjectiveFor Part 1:The primary objective is to characterize the pharmacokinetics (PK) and to confirm the population PK (popPK) model derived from healthy volunteers in hospitalized adults who are infected with RSV.For Part 2:The primary…

An Open-label, Randomized, Multi-center, Parallel Group, Two-arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir versus Standard of Care for Treatment of Adenovirus Infections in High-risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients

The primary objective of this study is to compare the safety, overall tolerability, and virologic response of BCV vs. SoC (i.e., investigator-assigned therapy) for the treatment of AdV infection in high-risk pediatric allogeneic HCT recipients. A…

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With
Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection

The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to *85 years) compared to adults (aged 18 to *64 years) with influenza A infection.

A phase IIa randomized, placebo controlled, double blinded study to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy.

To evaluate the safety and immunogenicity of iHIVARNA-01 as a new therapeutic vaccine in HIV infected patients.