Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition...
COVID-19The primary objective of the study is to evaluate the efficacy of a single dose of OKZ (64 mg) vs placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 29.
LIBERATE Trial in COVID-19
CoronavirusRespiratory Distress Syndrome1 moreThe study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.
Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
Coronavirus InfectionsSARS-CoV 22 moreThe Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.
Systematic Offer of Nurse-Driven Screening for COVID-19 in Emergency Departments in the Paris Metropolitan...
SARS-CoV InfectionNurse's RoleEuropean countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters. Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population. To the best the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area, one of the most SARS-CoV2 affected regions. The aim is to evaluate the benefit of a systematic offer of SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy) The strategies will be compared during two periods following a cluster-randomized two-period crossover design. During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients using a PCR multiplex for symptomatic patients and a RT-LAMP for asymptomatic patients.
A Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)TAK-019 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-019 can protect people from Covid-19 and to check for side effects from TAK-019. At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-019 or a placebo in their arm. In this study, a placebo will look like the TAK-019 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-019 than placebo. Participants will receive 2 injections of TAK-019 or placebo, 21 days apart. Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection. During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have attended a clinic visit 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19. The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-019 or the placebo.
Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus...
Covid19The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants. The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.
Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to...
Severe Acute Respiratory Syndrome Coronavirus 2Metabolic Syndrome1 moreThe purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine
Covid19SARS-CoV Infection1 moreRandomized, blind, placebo-controlled phase- i study and randomized, open phase phase-ii study of QAZCOVID-IN®- COVID-19 inactivated vaccine in healthy adult volunteers from 18 years old and elder
Proxalutamide Treatment for COVID-19 Female Outpatients
Covid19SARS-CoV InfectionThis study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Phase 3 Boosting Study for the SARS-CoV-2 rS Vaccine
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)This is an observer-blinded Phase 3 study to evaluate the safety and immunogenicity of a single booster dose of the Novavax severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine adjuvanted with Matrix-MTM (NVX-CoV2373) in adults previously vaccinated with the BBIBP-CorV vaccine. The study will enroll approximately1,000 participants >18 years of age. All participants will be randomized in a 1:1 ratio to receive a single booster dose of NVX-CoV2373 or the BBIBP-CorV vaccine. All participants will receive the booster dose on Day 0 and remain on study for immunogenicity and safety data collection through Day 180. An interim analysis will be performed of safety and immunogenicity data gathered through Day 28.