Influenza Infection Clinical Trial
Official title:
A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Cohort 1: It is designed as a two stage, multi-center, randomized, double-blind, two parallel
doses, placebo-controlled study that will investigate the efficacy of DAS181 for the
treatment of serious IFV in hospitalized patients who suffered from acute hypoxemia requiring
supplemental oxygen therapy.
Cohort 2: It is designed as an open-label study that will investigate the efficacy of DAS181
for the treatment of patients with sever IFV but not eligible for Cohort 1 and non-IFV SAD
viral infection, e.g. parainfluenza virus, human metapneumovirus, enterovirus and all strains
of β-coronaviruses (including but not limited to SARS-CoV-2), with hypoxemia requiring
supplemental oxygen therapy.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00603811 -
Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT03784885 -
A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult
|
Phase 2 | |
| Recruiting |
NCT05436444 -
Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model
|
Phase 1 | |
| Completed |
NCT01201902 -
A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine
|
Phase 3 | |
| Completed |
NCT00559975 -
Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
|
Phase 1 | |
| Terminated |
NCT00647465 -
Effect of the Interferon Alpha Citizen by Sub-Lingual Way on the Humoral Immunizing Answer
|
Phase 3 | |
| Recruiting |
NCT01225770 -
Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers
|
Phase 3 | |
| Completed |
NCT01008020 -
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
|
N/A | |
| Completed |
NCT00239213 -
Catechin Gargling for Influenza Infection
|
N/A | |
| Terminated |
NCT04933968 -
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT01049490 -
Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device
|
N/A | |
| Completed |
NCT02367885 -
Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants
|
Phase 1/Phase 2 | |
| Completed |
NCT02313155 -
Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT00812448 -
Catechin Containing Mask for the Prevention of Influenza Infection
|
N/A | |
| Active, not recruiting |
NCT05818124 -
Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)
|
Phase 1 | |
| Terminated |
NCT01160237 -
Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM
|
Phase 3 | |
| Completed |
NCT03814720 -
Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults
|
Phase 1 |