Clinical trial • Phase III • Infectious Disease

MOLNUPIRAVIR for COVID-19 | SARS-CoV-2 infection

Phase III trial of MOLNUPIRAVIR for COVID-19 | SARS-CoV-2 infection.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
COVID-19 | SARS-CoV-2 infection
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
08-10-2024
First CTIS Authorization Date
06-02-2025

Trial design

Randomised, molnupiravir matching placebo tablets (placebo arm); dose and schedule not specified in provided documents-controlled Phase III trial across 49 sites in Finland, Poland, France and others.

Randomised
Yes
Comparator
Molnupiravir Matching placebo tablets (placebo arm); dose and schedule not specified in provided documents
Target Sample Size
2315
Trial Duration For Participant
29

Eligibility

Recruits 2315 No vulnerable population selected; participants are adults (≥18 years of age). Consent is obtained from the participant (no assent procedures described)..

Vulnerable Population
No vulnerable population selected; participants are adults (≥18 years of age). Consent is obtained from the participant (no assent procedures described).

Inclusion criteria

  • {"criterion_text":"- Is an individual of any sex/gender, ≥18 years of age\n- Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization\n- Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever >38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache\n- Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19: 1) advanced age of ≥75 years of age, 2) Immunocompromised, 3) Neurocognitive or physical disability or has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g. diabetes, obesity with body mass index (BMI) ≥ 35, chronic lung diseases)\n- Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following: 1) Is receiving drug(s) highly dependent on cytochrome P450 (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible, 2) Is receiving potent CYP3A inducers where significantly reduces nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance, 3) Has severe hepatic impairment, 4) Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use, 5) Has known or suspected NMV/r resistance, 6) Has uncontrolled HIV infection, 7) NMV/r is not approved/authorized in the participant’s country or it is not accessible to participant (e.g. drug shortage), 8) Is unwilling to receive treatment with NMV/r"}

Exclusion criteria

  • {"criterion_text":"- Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently\n- Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)\n- Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19: 1) shortness of breath at rest, 2) respiratory rate ≥30 breaths per minute, 3) heart rate ≥125 beats per minute, 4) peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms, 5) New or increasing need for supplemental oxygen: Receiving >4 liters/min supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19\n- Has received a COVID-19 vaccine within 30 days prior to randomization\n- Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization\n- Has known or suspected hypersensitivity to active or inactive ingredients of MOV"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants Who Experienced One or More of following through Day 29: Hospitalization, All-cause Mortality, or COVID-19 Related Medically Attended Visit (MAV)","definition_or_measurement_approach":"Assessed in the mITT population from randomization through Day 29; measured as the percentage of participants with one or more of: hospitalization (all-cause), death (all-cause), or a COVID-19-related medically attended visit (MAV)."}
  • {"endpoint_text":"- Percentage of Participants Who Experienced an Adverse Event (AE)","definition_or_measurement_approach":"Safety endpoint assessed in the APaT population as the percentage of participants reporting one or more adverse events during the study period."}
  • {"endpoint_text":"- Percentage of Participants Who Discontinued Study Intervention Due to AE","definition_or_measurement_approach":"Measured as the percentage of participants who discontinued the study intervention because of adverse events during the study."}

Secondary endpoints

  • {"endpoint_text":"- Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms","definition_or_measurement_approach":"Time-to-event measured from randomization through Day 29 in the mITT population (time to sustained alleviation without relapse)."}
  • {"endpoint_text":"- Change From Baseline in SARS-CoV-2 RNA titer","definition_or_measurement_approach":"Change from baseline in SARS-CoV-2 RNA titer measured in nasopharyngeal (NP) swabs at Day 3, End of Treatment (EOT), and Days 10, 14, and 29 in the mITT population."}
  • {"endpoint_text":"- Percentage of Participants With Undetectable SARS-CoV-2 RNA","definition_or_measurement_approach":"Measured as the percentage of participants with undetectable SARS-CoV-2 RNA in NP swabs at specified timepoints (Day 3, EOT, Days 10, 14, 29) in the mITT population."}
  • {"endpoint_text":"- Percentage of Participants Who Experienced One or More of following through Day 29: All-cause Hospitalization or All-cause Mortality","definition_or_measurement_approach":"Assessed in the mITT population from randomization through Day 29 as the percentage experiencing hospitalization (all-cause) or death (all-cause)."}
  • {"endpoint_text":"- Percentage of Participants With Clinically Important Medical Interventions Associated with COVID-19 related MAV or COVID-19 related hospitalization through Day 29","definition_or_measurement_approach":"Measured as the percentage of participants with clinically important medical interventions associated with a COVID-19-related medically attended visit (MAV) or hospitalization from randomization through Day 29 in mITT participants with MAV and/or hospitalization."}
  • {"endpoint_text":"- Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29","definition_or_measurement_approach":"Time-to-event measured from randomization through Day 29 in the mITT population (sustained alleviation without relapse of 15 self-reported signs/symptoms)."}
  • {"endpoint_text":"- Time to Sustained Resolution Without Relapse of all 8 (5 prespecified and 3 determined by baseline prevalence) self-reported COVID-19 signs/symptoms through Day 29","definition_or_measurement_approach":"Time-to-event measured from randomization through Day 29 in the mITT population (sustained resolution without relapse of the 8 selected self-reported signs/symptoms)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
2315
Recruitment Window Months
74
Consent Approach
Informed consent obtained from each participant (adults ≥18 years). Subject information and ICF documents are provided (local language and English versions available per country). Optional/ancillary consent forms (e.g., pregnancy follow-up, infant follow-up, optional procedures) are available in some countries. No assent procedures described (adult-only population).

Methods

  • Poster (site posters) — patient-facing printed posters used in participating sites (documents present for multiple countries, e.g., POL, FRA, ESP, ITA, DEU)
  • Patient flyer / Patient brochure — printed patient information flyers used at sites and for distribution to potential participants (country-specific versions present e.g., POL, FRA, ESP, ITA, DEU, ROU, BGR, FIN)
  • Social media (posts and social media text) — digital recruitment via social media channels (country-specific social media materials available, e.g., POL, FRA, ITA)
  • Website — study-specific website content/pages for recruitment (documents for Poland and others)
  • Advertisement (online/print) — advertisements prepared for recruitment (country-specific advertising materials present, e.g., FRA, DEU)
  • Patient letter / invitation — letters to potential participants (documents available e.g., FRA)

Geography

Total Number Of Sites
49
Total Number Of Participants
767

Finland

Earliest CTIS Part Ii Submission Date
16-01-2025
Latest Decision Or Authorization Date
19-12-2025
Processing Time Days
337
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
HUS-Yhtymae
Department Name
MeVac – Meilahti Vaccine Research Center
Principal Investigator Name
Hanna Välimaa
Principal Investigator Email
hanna.valimaa@hus.fi
Contact Person Name
Hanna Välimaa
Contact Person Email
hanna.valimaa@hus.fi

Poland

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
354
Number Of Sites
7
Number Of Participants
120

Sites

Site Name
EMC Instytut Medyczny S.A.
Department Name
PL Certus Szpital Nr 1, PL Certus Ambulatorium
Principal Investigator Name
Małgorzata Stasiak-Paczkowska
Principal Investigator Email
Kinga.kieronczyk@emc-sa.pl
Contact Person Name
Małgorzata Stasiak-Paczkowska
Contact Person Email
Kinga.kieronczyk@emc-sa.pl
Site Name
Clinical Medical Research Sp. z o.o.
Principal Investigator Name
Piotr Wilczek
Principal Investigator Email
contact@clinicalmedicalresearch.pl
Contact Person Name
Piotr Wilczek
Site Name
Gyncentrum Sp. z o.o. (Katowice)
Department Name
NZOZ Holsamed - Oddział Libero
Principal Investigator Name
Jakub Kwiatkowski
Principal Investigator Email
badaniakliniczne@holsaclinical.pl
Contact Person Name
Jakub Kwiatkowski
Site Name
Gyncentrum Sp. z o.o. (Cracow)
Department Name
NZOZ GynCentrum - Oddział Kraków
Principal Investigator Name
Wojciech Sydor
Principal Investigator Email
badaniakliniczne@holsaclinical.pl
Contact Person Name
Wojciech Sydor
Site Name
Gyncentrum Sp. z o.o. (Bielsko-Biala)
Department Name
NZOZ GynCentrum - Oddział Bielsko-Biała
Principal Investigator Name
Adrianna Gęga-Czarnota
Principal Investigator Email
badaniakliniczne@holsaclinical.pl
Contact Person Name
Adrianna Gęga-Czarnota
Site Name
In Vivo Sp. z o.o.
Principal Investigator Name
Piotr Piasecki
Principal Investigator Email
kontakt@in-vivo.pl
Contact Person Name
Piotr Piasecki
Contact Person Email
kontakt@in-vivo.pl
Site Name
EMC Instytut Medyczny S.A. (Wroclaw)
Department Name
Penta Hospitals Przychodnie, Wrocław Wejherowska
Principal Investigator Name
Wojciech Gandecki
Principal Investigator Email
badania.kliniczne@pentahospitals.pl
Contact Person Name
Wojciech Gandecki

France

Earliest CTIS Part Ii Submission Date
10-01-2025
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
383
Number Of Sites
4
Number Of Participants
120

Sites

Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Centre d'investigation clinique
Principal Investigator Name
Marc BARDOU
Principal Investigator Email
marc.bardou@u-bourgogne.fr
Contact Person Name
Marc BARDOU
Contact Person Email
marc.bardou@u-bourgogne.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Maladies infectieuses
Principal Investigator Name
Valérie POURCHER
Principal Investigator Email
valerie.martinez@aphp.fr
Contact Person Name
Valérie POURCHER
Contact Person Email
valerie.martinez@aphp.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Urgences
Principal Investigator Name
Alain VIALLON
Principal Investigator Email
alain.viallon@chu-st-etienne.fr
Contact Person Name
Alain VIALLON
Site Name
Hospices Civils De Lyon
Department Name
Allergologie et Immunologie Clinique - LYREC
Principal Investigator Name
Fréderic BERARD
Principal Investigator Email
frederic.berard@chu-lyon.fr
Contact Person Name
Fréderic BERARD
Contact Person Email
frederic.berard@chu-lyon.fr

Spain

Earliest CTIS Part Ii Submission Date
14-11-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
432
Number Of Sites
11
Number Of Participants
180

Sites

Site Name
Hospital General Universitario Santa Lucia
Department Name
Internal Medicine
Principal Investigator Name
Francisco Vera Méndez
Principal Investigator Email
franciscovera72@gmail.com
Contact Person Name
Francisco Vera Méndez
Contact Person Email
franciscovera72@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pneumology
Principal Investigator Name
Francisco Javier González Barcala
Contact Person Name
Francisco Javier González Barcala
Site Name
Hospital Universitario Infanta Leonor
Department Name
Internal Medicine
Principal Investigator Name
Jorge Antonio Valencia La Rosa
Principal Investigator Email
jorge_vlr@yahoo.es
Contact Person Name
Jorge Antonio Valencia La Rosa
Contact Person Email
jorge_vlr@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Infectious diseases
Principal Investigator Name
Oscar Manual Len Abad
Principal Investigator Email
oscarmanuel.len@vallhebron.cat
Contact Person Name
Oscar Manual Len Abad
Contact Person Email
oscarmanuel.len@vallhebron.cat
Site Name
Hospital General Universitario De Elche
Department Name
Infectious diseases
Principal Investigator Name
Sergio Padilla Urrea
Principal Investigator Email
sergiopadurr@gmail.com
Contact Person Name
Sergio Padilla Urrea
Contact Person Email
sergiopadurr@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Internal Medicine
Principal Investigator Name
Lourdes Mateu Pruñonosa
Principal Investigator Email
lmateu@lluita.org
Contact Person Name
Lourdes Mateu Pruñonosa
Contact Person Email
lmateu@lluita.org
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Internal Medicine
Principal Investigator Name
Juan Emilio Losa García
Principal Investigator Email
juanemilio.losa@salud.madrid.org
Contact Person Name
Juan Emilio Losa García
Site Name
Eap Osona Sud Alt Congost S.L.P.
Principal Investigator Name
Silvia Narejos Pérez
Principal Investigator Email
snarejos@ebacentelles.cat
Contact Person Name
Silvia Narejos Pérez
Contact Person Email
snarejos@ebacentelles.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Internal Medicine
Principal Investigator Name
Enrique Miguez Rey
Principal Investigator Email
enrique.miguez.rey@sergas.es
Contact Person Name
Enrique Miguez Rey
Contact Person Email
enrique.miguez.rey@sergas.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Infecious diseases
Principal Investigator Name
Manuel Francisco Liroa Romero
Principal Investigator Email
manlirrom@gmail.com
Contact Person Name
Manuel Francisco Liroa Romero
Contact Person Email
manlirrom@gmail.com
Site Name
Equip D'Atencio Primaria Barcelona Sardenya S.L.P.
Department Name
Primary Care
Principal Investigator Name
Carlen Reyes Reyes
Principal Investigator Email
creyes@eapsardenya.cat
Contact Person Name
Carlen Reyes Reyes
Contact Person Email
creyes@eapsardenya.cat

Romania

Earliest CTIS Part Ii Submission Date
14-01-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
363
Number Of Sites
6
Number Of Participants
64

Sites

Site Name
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Department Name
Boli Infectioase
Principal Investigator Name
Violeta Briciu
Principal Investigator Email
contact@infectioasecluj.ro
Contact Person Name
Violeta Briciu
Contact Person Email
contact@infectioasecluj.ro
Site Name
Sana Monitoring S.R.L.
Principal Investigator Name
Adrian Sarbu
Principal Investigator Email
adrian.sarbu@sana.ro
Contact Person Name
Adrian Sarbu
Contact Person Email
adrian.sarbu@sana.ro
Site Name
Spitalul Clinic De Boli Infectioase Constanta
Department Name
Boli Infectioase Adulti II
Principal Investigator Name
Irina Dumitru
Principal Investigator Email
contact@infectioaseconstanta.ro
Contact Person Name
Irina Dumitru
Site Name
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Principal Investigator Name
Simona Tetradov
Principal Investigator Email
office@spitalulbabes.ro
Contact Person Name
Simona Tetradov
Contact Person Email
office@spitalulbabes.ro
Site Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Principal Investigator Name
Anca Streinu-Cercel
Principal Investigator Email
secretariatinbi@mateibals.ro
Contact Person Name
Anca Streinu-Cercel
Contact Person Email
secretariatinbi@mateibals.ro
Site Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals (additional site)
Department Name
Boli Infectioase Adulti II
Principal Investigator Name
Liliana Preotescu
Principal Investigator Email
secretariatinbi@mateibals.ro
Contact Person Name
Liliana Preotescu
Contact Person Email
secretariatinbi@mateibals.ro

Germany

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
369
Number Of Sites
4
Number Of Participants
35

Sites

Site Name
University Hospital Cologne AöR
Department Name
Innere Medizin I, Infektionsambulanz und Tagesklinik
Principal Investigator Name
Clara Lehmann
Principal Investigator Email
infektiologie-studienbuero@uk-koeln.de
Contact Person Name
Clara Lehmann
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin
Principal Investigator Name
Eva Schrezenmeier
Principal Investigator Email
nephrologie-studien@charite.de
Contact Person Name
Eva Schrezenmeier
Contact Person Email
nephrologie-studien@charite.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Innere Medizin II
Principal Investigator Name
Jochen Schneider
Principal Investigator Email
annette.schuster@mri.tum.de
Contact Person Name
Jochen Schneider
Contact Person Email
annette.schuster@mri.tum.de
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II, Infektiologie und Therapie der HIV-Infektionen
Principal Investigator Name
Maria Vehreschild
Principal Investigator Email
maria.vehreschild@kgu.de
Contact Person Name
Maria Vehreschild
Contact Person Email
maria.vehreschild@kgu.de

Italy

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
443
Number Of Sites
4
Number Of Participants
83

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
UO Malattie Infettive 3
Principal Investigator Name
Agostino Riva
Principal Investigator Email
agostino.riva@asst-fbf-sacco.it
Contact Person Name
Agostino Riva
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Malattie Infettive, Dipartimento di Medicina Clinica e Sperimentale -
Principal Investigator Name
Marco Falcone
Principal Investigator Email
marco.falcone@unipi.it
Contact Person Name
Marco Falcone
Contact Person Email
marco.falcone@unipi.it
Site Name
IRCCS Azienda Ospedaliera Metropolitana
Department Name
Clinica Malattie Infettive
Principal Investigator Name
Matteo Bassetti
Principal Investigator Email
matteo.bassetti@hsanmartino.it
Contact Person Name
Matteo Bassetti
Contact Person Email
matteo.bassetti@hsanmartino.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UO Malattie Infettive
Principal Investigator Name
Caterina Campoli
Principal Investigator Email
caterina.campoli@aosp.bo.it
Contact Person Name
Caterina Campoli
Contact Person Email
caterina.campoli@aosp.bo.it

Bulgaria

Earliest CTIS Part Ii Submission Date
31-01-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
453
Number Of Sites
12
Number Of Participants
150

Sites

Site Name
Medical Center Medconsult Burgas EOOD
Principal Investigator Name
Kristiyan Kostov
Principal Investigator Email
medconsultburgas@abv.bg
Contact Person Name
Kristiyan Kostov
Contact Person Email
medconsultburgas@abv.bg
Site Name
Medical Centre Pratia Clinic EOOD
Principal Investigator Name
Iskra Velichkova
Principal Investigator Email
varna@leoclinics.com
Contact Person Name
Iskra Velichkova
Contact Person Email
varna@leoclinics.com
Site Name
DCC V Plovdiv EOOD
Principal Investigator Name
Viktoria Dimova
Principal Investigator Email
dkc5_plovdiv@abv.bg
Contact Person Name
Viktoria Dimova
Contact Person Email
dkc5_plovdiv@abv.bg
Site Name
Medical Center Hera EOOD (Montana)
Principal Investigator Name
Vanko Vankov
Principal Investigator Email
office@heraclinics.com
Contact Person Name
Vanko Vankov
Contact Person Email
office@heraclinics.com
Site Name
Medical Center Medconsult Pleven OOD
Principal Investigator Name
Maria Tzekova
Principal Investigator Email
mcpleven@abv.bg
Contact Person Name
Maria Tzekova
Contact Person Email
mcpleven@abv.bg
Site Name
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
Department Name
Pneumology Department
Principal Investigator Name
Hristo Metev
Principal Investigator Email
pulmo_dispaser@rousse.spnet.net
Contact Person Name
Hristo Metev
Site Name
Medical Center Medconsult Pleven OOD (Lovech)
Principal Investigator Name
Ana Kostadinovska
Principal Investigator Email
mcloveck@abv.vg
Contact Person Name
Ana Kostadinovska
Contact Person Email
mcloveck@abv.vg
Site Name
Medical Center Zdrave-1 OOD
Principal Investigator Name
Rumen Tiholov
Principal Investigator Email
zdrave1_kozloduy@abv.bg
Contact Person Name
Rumen Tiholov
Contact Person Email
zdrave1_kozloduy@abv.bg
Site Name
Medical Center Hera EOOD (Sofiya)
Principal Investigator Name
Kiril Palaveev
Principal Investigator Email
office@heraclinics.com
Contact Person Name
Kiril Palaveev
Contact Person Email
office@heraclinics.com
Site Name
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
Department Name
Department of Pneumology and Phthisiatry
Principal Investigator Name
Lidiya Nikolcheva-Todorova
Principal Investigator Email
mbalmont@net-surf.net
Contact Person Name
Lidiya Nikolcheva-Todorova
Contact Person Email
mbalmont@net-surf.net
Site Name
Diagnostic-Consultative Center 22 Sofia EOOD
Principal Investigator Name
Rumyana Gudzeva
Principal Investigator Email
info@22dkc.com
Contact Person Name
Rumyana Gudzeva
Contact Person Email
info@22dkc.com
Site Name
Medical Center Asclepius Ltd.
Principal Investigator Name
Savka Vaklyova
Principal Investigator Email
lybkadafova@abv.bg
Contact Person Name
Savka Vaklyova
Contact Person Email
lybkadafova@abv.bg

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Pharmaceutical Product Development LLC
Responsibilities
code:4
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Almac Clinical Services LLC
Responsibilities
code:3

Third parties

  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Biorepository","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"DDL Diagnostic Laboratory B.V.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Axio Research","duties_or_roles":"Statistical analysis","organisation_type":"SME"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Patient Locator for follow up","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
molnupiravir
Active Substance
MOLNUPIRAVIR
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorized (prodAuthStatus=1; EU MP number PRD11141081)
Maximum Dose
Max daily dose 1600 mg; max total dose 8000 mg; max treatment period 5 days
Investigational Product Name
Molnupiravir Matching placebo tablets
Modality
Other
Authorisation Status
Not applicable / matching placebo

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