Trial of Treatments for COVID-19 in Hospitalized Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

1,552

Participants

Timeline

Start Date

March 22, 2020

Primary Completion Date

July 9, 2022

Study Completion Date

September 25, 2023

Conditions
Corona Virus Infection
Interventions
DRUG

Remdesivir

The lyophilized formulation of Remdesivir is a preservative-free, white to off-white or yellow, lyophilized solid containing 100 mg of Remdesivir to be reconstituted with 19 mL of sterile water for injection and diluted into IV infusion fluids prior to IV infusion. Following reconstitution, each vial contains a 5 mg/mL Remdesivir concentrated solution with sufficient volume to allow withdrawal of 20 mL (100 mg of remdesivir). It is supplied as a sterile product in a single-use, 30 mL, Type 1 clear glass vial.

DRUG

Lopinavir/ritonavir

"The oral tablets of lopinavir/ritonavir contain 200 mg lopinavir, 50 mg ritonavir. They have a yellow colour, film-coated, ovaloid shape debossed with the a logo and the code KA. The oral solution for patients who cannot swallow is a light yellow to orange colored liquid containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL)."

DRUG

Interferon Beta-1A

IFN-ß-1a is supplied as a sterile solution containing no preservative available in a prefilled syringe. It will be provided as a single-dose prefilled graduated syringe with 44 µg per 0.5 mL. The liquid should be clear to slightly yellow. Do not use if the liquid is cloudy, discolored or contains particles. Use a different syringe.

DRUG

Hydroxychloroquine

Hydroxychloroquine is supplied as film-coated 200 mg tablets. Hydroxychloroquine sulfate tablets are presented as white or whitish, peanut-shaped, oblong or round film-coated tablets containing 200 mg of hydroxychloroquine sulfate (equivalent to 155 mg base).

OTHER

Standard of care

Standard of care

DRUG

AZD7442

AZD7442 will be supplied as separate vials of AZD8895 and AZD1061 containing 150 mg colorless to slightly yellow, clear to opalescent solutions for injection.

OTHER

Placebo

Since April, 2021, the placebo will be a 0.9% (w/v) NaCl solution for infusion also called saline. The placebo will be supplied as a single 10-mL, clear and colorless vial.

Trial Locations (62)

1070

Hôpital Erasme - Cliniques universitaires de Bruxelles, Brussels

1200

Hôpital Saint Luc, Brussels

4000

Hôpital La Citadelle, Liège

5020

Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg

6020

Medizinische Universität Innsbruck, Innsbruck

21000

Centre Hospitalier Universitaire Dijon-Bourgogne, Dijon

25000

Centre Hospitalier Régional Universitaire de Besançon, Besançon

31000

Centre Hospitalier Universitaire de Toulouse, Toulouse

31300

Centre Hospitalier Universitaire de Toulouse, Toulouse

33000

Centre Hospitalier Universitaire de Bordeaux, Bordeaux

34000

Centre Hospitalier Universitaire de Montpellier, Montpellier

35033

Centre Hospitalier Universitaire de Rennes, Rennes

37000

Centre Hospitalier Universitaire de Tours, Tours

38700

Centre Hospitalo-Universitaire de Grenoble, La Tronche

42055

Centre Hospitalier Universitaire de Saint Etienne, Saint-Etienne

44000

Centre Hospitalier Universitaire de Nantes, Nantes

51100

CHU de Reims, Reims

54000

Centre Hospitalier Régional et Universitaire de Nancy, Nancy

56000

CH Bretagne Atlantique, Vannes

57085

Centre Hospitalier Regional Metz-Thionville, Ars-Laquenexy

59000

Centre Hospitalier Régional Universitaire de Lille, Lille

59208

Centre Hospitalier de Tourcoing, Tourcoing

67000

Centre Hospitalier Régional Universitaire de Strasbourg, Strasbourg

68100

Groupe Hospitalier de la Région de Mulhouse Sud Alsace, Mulhouse

69000

Hospices Civils de Lyon, Lyon

74370

Centre Hospitalier Annecy Genevois, Épagny

75010

APHP - Hôpital Lariboisière, Paris

APHP - Hôpital Saint Louis, Paris

75012

APHP - Hôpital Saint Antoine, Paris

75013

APHP - Hôpital Universitaire Pitié Salpêtrière, Paris

75014

APHP - Hôpital Cochin, Paris

Hôpital Paris Saint-Joseph et Marie Lannelongue, Paris

75015

APHP - Hôpital Necker, Paris

APHP- Hôpital Européen Georges-Pompidou, Paris

75018

APHP - Hôpital Bichat Claude Bernard, Paris

75020

APHP - Hôpital Tenon, Paris

80054

Centre Hospitalier Universitaire Amiens-Picardie, Amiens

93200

Hopital DELAFONTAINE, Saint-Denis

94010

APHP - hôpital Henri-Mondor, Créteil

94160

Hôpital d'Instruction des Armées BEGIN, Saint-Mandé

94270

AP-HP Hôpital Bicêtre, Le Kremlin-Bicêtre

97261

Centre Hospitalier Universitaire de Martinique, Fort de France

97306

Centre Hospitalier Andrée Rosemon, Cayenne

Unknown

Kepler Universitätsklinikum Linz, Linz

Pôle Hospitalier Jolimont / site de Mons-Warquignies, Mons

CHU APHP Ambroise-Paré, Boulogne-Billancourt

Hospices Civil, Colmar

CHU Nîmes, Nîmes

CHU Poitiers, Poitiers

CH Cornouaille, Quimper

CH Bretagne Atlantique, Vannes

Evaggelismos General Hospital, Athens

General University Hospital of Patras, Pátrai

Akershus Unniversity Hospital, Oslo

Lovisenberg Diaconal Hospital, Oslo

Oslo University Hospital, Oslo

Hospital de Cascais, Cascais

CHULN- Hospital de Santa Maria, Lisbon

Centro Hospitalar Universitário de São João, EPE, Porto

06000

Centre Hospitalo-Universitaire de Nice, Nice

L-1210

Centre Hospitalier Luxembourg, Luxembourg

L-2450

Hôpitaux Robert Schuman, Luxembourg

All Listed Sponsors
lead

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

NCT04315948 - Trial of Treatments for COVID-19 in Hospitalized Adults | Biotech Hunter | Biotech Hunter