Coronavirus Infections Clinical Trial
— FrenchCOVIDOfficial title:
Clinical Characterisation Protocol for Severe Emerging Infections
Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility. The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.
| Status | Recruiting |
| Enrollment | 5000 |
| Est. completion date | August 7, 2025 |
| Est. primary completion date | August 7, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Any patient admitted to a health care facility, with an infection confirmed by SARS-CoV-2 (virologically confirmed diagnosis by PCR). Non inclusion criteria: - Subject deprived of freedom, subject under a legal protective measure - Refusal by participant, parent or appropriate representative. Exclusion Criteria: - Confirmed diagnosis of another pathogen than SARS-CoV-2 and no indication or likelihood of co-infection with SARS-CoV-2. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHG Agen | Agen | |
| France | Centre Hospitalier Du Pays D'aix | Aix-en-Provence | |
| France | CHU Amiens | Amiens | |
| France | CHU Angers | Angers | |
| France | CH Annecy Genevois | Annecy | |
| France | Hopital privé d'Antony | Antony | |
| France | Hôpital de Mercy. CHR METZ-THIONVILLE | Ars-Laquenexy | |
| France | Centre Hospitalier Henri Duffaut | Avignon | |
| France | Chu Jean Minjoz | Besançon | |
| France | Centre hospitalier de Béziers | Béziers | |
| France | Hôpital Avicenne AP-HP | Bobigny | |
| France | CHU Pellegrin | Bordeaux | |
| France | CHU Ambroise Paré | Boulogne-Billancourt | |
| France | Ch Fleyriat | Bourg-en-Bresse | |
| France | Centre Hospitalier Pierre Oudot | Bourgoin-Jallieu | |
| France | Chru Hopital Cavale Blanche | Brest | |
| France | CHU Brest | Brest | |
| France | Hospices civils de Lyon | Bron | |
| France | CH Cahors | Cahors | |
| France | Centre Hospitalier J.E Techer | Calais | |
| France | Centre Hospitalier Andrée Rosemon | Cayenne | |
| France | Chms Chambery Nh | Chambéry | |
| France | Centre Hospitalier De Cholet | Cholet | |
| France | CHU Gabriel Montpied | Clermont-Ferrand | |
| France | CH Colmar - Hopital Pasteur | Colmar | |
| France | Hôpital Louis Mourier | Colombes | |
| France | Centre hospitalier Alpes Leman | Contamine-sur-Arve | |
| France | Centre hospitalier Intercommunal de Créteil | Créteil | |
| France | Hôpital Henri Mondor | Créteil | |
| France | Centre Hospitalier Dax | Dax | |
| France | CHU Dijon Bourgogne | Dijon | |
| France | CH Annecy Genevois | Épagny | |
| France | CHU de Martinique | Fort De France | |
| France | Hopital Raymond Poincare | Garches | |
| France | CHU Grenoble | Grenoble | |
| France | Grand Hopital de l'Est Francilien site Marne-la-Vallée | Jossigny | |
| France | Chd Les Oudairies | La Roche-sur-Yon | |
| France | Hôpital Universitaire Bicêtre | Le Kremlin-Bicêtre | |
| France | CH du Mans | Le Mans | |
| France | Centre Hospitalier Emile Roux | Le Puy-en-Velay | |
| France | Centre Hospitalier Universitaire de Lille | Lille | |
| France | CHRU Lille, Hôpital Salengro | Lille | |
| France | CHU de Lille | Lille | |
| France | Hôpital de la Croix-Rousse | Lyon | |
| France | Hôpital Louis Raffalli | Manosque | |
| France | Assistance publique hopitaux de Marseille, hopital Nord | Marseille | |
| France | Hôpital Conception | Marseille | |
| France | Hopital Européen | Marseille | |
| France | Groupe Hospitalier Sud Ile De France | Melun | |
| France | CH de Mont Marsan | Mont de Marsan | |
| France | Groupe hospitalier du Havre | Montivilliers | |
| France | CHU Montpellier | Montpellier | |
| France | CHU Nantes | Nantes | |
| France | Hopital Américain de Paris | Neuilly-sur-Seine | |
| France | CHU de Nice | Nice | |
| France | CHU Caremeau | Nîmes | |
| France | APHP Bichat | Paris | |
| France | APHP Tenon | Paris | |
| France | CH Lariboisière | Paris | |
| France | Groupe Hospitalier Diaconesses Croix Saint-Simon | Paris | |
| France | Hopital Cochin-CIC1417 | Paris | |
| France | Hopital Européen Georges Pompidou | Paris | |
| France | Hopital Saint Antoine | Paris | |
| France | Hopital Saint Louis | Paris | |
| France | La pitié salpetrière | Paris | |
| France | Centre Hospitalier de Pau | Pau | |
| France | Centre Hospitalier de Périgueux | Périgueux | |
| France | CH de Perpignan | Perpignan | |
| France | Hopital Lyon Sud-HCL | Pierre-Bénite | |
| France | CHU de Pointe à Pitre | Pointe À Pitre | |
| France | CHU de Poitiers | Poitiers | |
| France | Ch Cornouaille | Quimper | |
| France | Chu Reims | Reims | |
| France | CHU Rennes Hopital Sud | Rennes | |
| France | Hôpital Pontchaillou | Rennes | |
| France | CHU Charles Nicole | Rouen | |
| France | CHU Rouen Normandie | Rouen | |
| France | CHU Réunion-Felix Guyon | Saint denis | |
| France | CHU de Saint-Etienne | Saint-Étienne | |
| France | Hopital d'instruction des armées Begin 69 | Saint-Mandé | |
| France | Centre hospitalier Louis Constant Fleming | Saint-Martin | |
| France | Groupe Hospitalier Sud Réunion | Saint-Pierre | |
| France | CH de Saintonge | Saintes | |
| France | Centre Hospitalier de Soissons | Soissons | |
| France | N.H.C. - Nouvel Hopital Civil | Strasbourg | |
| France | Hopital Foch | Suresnes | |
| France | CHR Metz-Thionville -Hopital Bel Air | Thionville | |
| France | Hopitaux du Leman | Thonon-les-Bains | |
| France | Centre Hospitalier Universitaire de Rangueil | Toulouse | |
| France | CHU de Toulouse | Toulouse | |
| France | CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse | Toulouse | |
| France | CHU Toulouse Larrey | Toulouse | |
| France | Hôpital Gustave Dron | Tourcoing | |
| France | Centre Hospitalier Régional Universitaire de Tours | Tours | |
| France | CHRU de Tours | Tours | |
| France | CHU Nancy | Vandœuvre-lès-Nancy | |
| France | Centre Hospitalier Bretagne Atlantique | Vannes | |
| France | Centre Hospitalier Intercommunal | Villeneuve Saint Georges |
| Lead Sponsor | Collaborator |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical features | Describe the clinical features of the illness or syndrome (cardio-respiratory signs or symptoms, and laboratory results) and complications, and determinants of severity.
Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months. |
18 months | |
| Primary | Response to treatment | Describe the response to treatments (including supportive care and novel therapeutics) by clinical, biological, radiological and virological assessments.
Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months. |
18 months | |
| Primary | Pathogen replication, excretion and evolution, within the host | high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months. |
18 months | |
| Primary | Immune host responses to infection and therapy | Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months. |
18 months | |
| Primary | Host genetic variants | Identify host genetic variants associated with disease progression or severity | Day 1 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04553575 -
CoViD-19 Patient in Reims University Hospital in March to April 2020
|
||
| Active, not recruiting |
NCT05033847 -
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
|
Phase 2 | |
| Active, not recruiting |
NCT05548439 -
Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901a
|
Phase 1 | |
| Completed |
NCT05046548 -
This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05726084 -
Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05069129 -
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT05054075 -
Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19
|
Phase 2 | |
| Recruiting |
NCT05599516 -
Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial
|
Phase 3 | |
| Completed |
NCT05047900 -
The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community
|
N/A | |
| Completed |
NCT04420286 -
Study of the Increase in ICU Beds Capacity During COVID-19 Pandemic in France
|
||
| Completed |
NCT04424355 -
Magnetic Resonance Imaging to Detect Signs of Viral Pneumonia in Patients With Coronavirus Infection.
|
||
| Completed |
NCT05083039 -
Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19
|
||
| Terminated |
NCT04409873 -
Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)
|
Phase 2 | |
| Enrolling by invitation |
NCT04327349 -
Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
|
N/A | |
| Completed |
NCT04321278 -
Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)
|
Phase 3 | |
| Recruiting |
NCT04327570 -
In-depth Immunological Investigation of COVID-19.
|
||
| Completed |
NCT04326309 -
Audio Data Collection for Identification and Classification of Coughing
|
||
| Recruiting |
NCT04322344 -
Escin in Patients With Covid-19 Infection
|
Phase 2/Phase 3 | |
| Completed |
NCT04323592 -
Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
|
||
| Completed |
NCT04328129 -
Household Transmission Investigation Study for COVID-19 in Tropical Regions
|
N/A |