Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
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|ClinicalTrials.gov Identifier: NCT04878055|
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : September 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Viral||Drug: Reparixin Other: Placebo||Phase 3|
This is a phase 3 clinical trial designed as a randomized, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of Reparixin in hospitalized adult patients with severe COVID-19 pneumonia.
Patients will be screened for the participation in the study and eventually randomized based on an unbalanced randomization scheme (2:1) to Reparixin oral tablets (2 x 600 mg TID) for up to 21 days or to placebo.
An unequal randomization is justified by the need to gain experience and more safety data with the investigated treatment and by an expected better acceptability of the trial by patients.
The placebo control arm is justified by the unavailability of a well-defined standard of care for subjects with COVID-19 pneumonia who are candidates for this study.
All patient will receive the standard supportive care based on the patient's clinical need. Follow-up information on the patient's clinical condition will be collected until day 90.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||subjects will be randomized with a 2:1 randomization ratio|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia|
|Actual Study Start Date :||February 14, 2021|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||October 2021|
Reparixin oral tablets, 1200 mg three times daily (TID) (2 tablets 600 mg each, TID) for up to 21 days or until decision of discharge from the hospital, on top of standard supportive care
2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).
Other Name: DF 1681Y
Placebo Comparator: Placebo
placebo, 2 tablets TID (identical to Reparixin tablets) for up to 21 days or until decision of discharge from the hospital, on top of standard supportive care.
Matched placebo, i.e. 2 tablets for the total of three daily administrations (6 tablets daily).
- Proportion of patients alive and free of respiratory failure at Day 28 [ Time Frame: At day 28 ]
- Proportion of patients alive and free of respiratory failure at day 60 [ Time Frame: At day 60 ]
- Mortality rates up to Day 28 [ Time Frame: Up to Day 28 ]
- Incidence of ICU admission until Day 28 [ Time Frame: Until day 28 ]
- Time to recovery (category 1 - 2 - 3 of the 7-point WHO Ordinal Scale of clinical improvement (WHO-OS)) until Day 28 [ Time Frame: Until Day 28 ]
- Proportion of patients alive and free of respiratory failure at fixed time-points [ Time Frame: At Days 3, 7(±1),14(±2), 21(±2), 28 (±2), 60(±2) after randomization (randomization = day 1) ]
- Incidence of Adverse Events (AEs) [ Time Frame: From randomization till the last follow-up, up to 90 days. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878055
|Contact: Maria De Pizzol, BSc, PhD||+39 02 firstname.lastname@example.org|
|Contact: Giovanna Di Turi, BSc||+39 02 email@example.com|
|Principal Investigator:||Giovanni Landoni, MD||IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione|