Evaluation of the efficacy, safety and tolerability of alisporivir for the treatment of hospitalised patients with infections due to SARS-CoV-2 (COVID-19). A randomised, open-label, proof of concept, Phase 2 study. - CYCLOVID

Assistance Publique - Hôpitaux Paris0 sites100 target enrollmentMay 22, 2020

ConditionsThe study population will consist of adults (18-80 years old) hospitalised for =48 hours prior to randomisation with a diagnosis of COVID-19 based on symptoms onset and SARS-CoV-2 RT-PCR test positive from nasopharyngeal swab. Patients with ARDS or patients requiring mechanical ventilation at screening or randomisation will be excluded MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: The study population will consist of adults (18-80 years old) hospitalised for =48 hours prior to randomisation with a diagnosis of COVID-19 based on symptoms onset and SARS-CoV-2 RT-PCR test positive from nasopharyngeal swab. Patients with ARDS or patients requiring mechanical ventilation at screening or randomisation will be excluded
Sponsor: Assistance Publique - Hôpitaux Paris
Enrollment: 100
Status: Active, Not Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 22, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux Paris

Eligibility Criteria

Inclusion Criteria

•1\.Adult males and females \=18 years and \=80 years of age at the time of screening.
•2\.Are hospitalised during the screening period with duration of hospitalisation prior to randomisation \=48 hours.
•3\.Have a diagnosis of COVID\-19 based on symptoms onset and SARS\-CoV\-2 RT\-PCR test positive from nasopharyngeal swab.
•4\.Have at least one (1\) of the following:
•a.Radiographic pulmonary infiltrates (CT scan), AND/OR
•b.Clinical assessment (evidence of rales/crackles on exam) AND SpO2 \=94% on room air, AND/OR
•c.Requirement of supplemental oxygen.
•5\.If female, of non\-childbearing potential (e.g. post\-menopausal as demonstrated by FSH or surgical sterilization i.e., tubal ligation or hysterectomy), or if of childbearing potential, be willing to commit to either sexual abstinence or use of at least 2 medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from screening through 7 months after last alisporivir dose.
•6\.If male, a willingness to refrain from donating sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation) from screening through 4 months after last alisporivir dose.
•7\.Willing and able to provide written informed consent.

Exclusion Criteria

•1\.Patients with ARDS or patients requiring mechanical ventilation at screening or randomisation.
•2\.In the opinion of the investigator, the patient is unlikely to survive the following 7 days after randomisation due to a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock.
•3\.Patients who are unconscious or considered by the investigator unable to consent.
•4\.Other severe co\-morbidity with life expectancy \=3 months according to the investigator’s assessment.
•5\.Critically ill patients who have an APACHE II score \=30\.
•6\.Concomitant severe bacterial infection including blood stream infections, endocarditis, osteomyelitis, retroperitoneal abscess, septic arthritis, or meningitis diagnosed within 7 days prior to randomisation (bacterial pulmonary infection that may complicate COVID\-19 is not an exclusion criterion).
•7\.Any of the following signs of severe sepsis:
•a.Shock or profound hypotension defined as systolic blood pressure \=90 mm Hg or a decrease of \=40 mm Hg from the value obtained during screening (if more than one measurement is taken) that is not responsive to fluid challenge.
•b.Hypothermia (core temperature \= 35\.6°C).
•c.DIC as evidenced by PT, PTT 2 × ULN, or platelets \= 50% of the LLN.