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Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial.

ABSTRACT:

SUBMITTER: Caballero Bermejo AF

PROVIDER: S-EPMC7492787 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesObjective: To undertake a pilot, feasibility RCT of umbilical cord blood derived cell therapy for treatment of adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent progression to severe ARDS.HypothesisExpanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties.Trial designPilot, parallel design randomised controlled trial.ParticipantsThe trial will recruit 24 hospitalised patients with confirmed SARS-CoV-2 infection and pneumonia from July to December 2020 at Monash Medical Centre in Melbourne, Australia.Intervention and comparatorIntervention: Intravenous injection of expanded umbilical cord blood cells at a dose of 5 million cells/kg (maximum dose - 500 million cells). Cell infusion will occur over 30-60 minutes through a peripheral intravenous cannula. Standard supportive care will continue as needed. Comparator: Standard supportive care.Main outcomesSafety and tolerability of cell administration within first 24 hours of administration; clinical improvement on a seven-category clinical improvement ordinal scale.RandomisationRandomisation will be done using computer generated allocation to intervention/ control groups in a 1:1 ratio (in blocks of 6) using sealed opaque envelopes.Blinding (masking)This will be an unblinded study, given that it is the first study using expanded cord blood cells in COVID-19 patients. There will be no placebo infusion.Numbers to be randomised (sample size)Twelve participants in each group. Total n=24.Trial statusCBC-19 protocol v2, dated 23rd April 2020. Recruitment has not started yet. Estimated recruitment timeline is between 1st July - 31st December 2020.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12620000478910, registered 16th April 2020.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Project description:ObjectivesTo evaluate the efficacy of early treatment with prednisone to decrease the progression of COVID-19 pneumonia.Trial designThis is a pragmatic, non-blinded, randomized, two arms, parallel trial.ParticipantsPatients between 18 and 90 years, with COVID-19 pneumonia, confirmed by RT PCR. The setting for the trial is the Hospital Santiago Oriente which is a secondary level hospital with an emergency room, intensive care, and all basic specialties of medicine.Inclusion criteria18 years or more COVID-19 confirmed by RT-PCR Oxygen requirements up to 35% by venturi mask or 5 liters per minute by nasal cannula (approximately FiO2 40%) Consent form signed Exclusion Criteria: Previous steroid use for more than 48 hours. Pregnancy Chronic respiratory failure Requirements of mechanical ventilation (invasive or no invasive) Chronic liver damage Child Pugh B or C Chronic kidney disease stage IV or V. Immunosuppressed Participation in another trial.Intervention and comparatorExperimental arm Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8. Usual care defined by the attending physician. Control arm No intervention. Usual care defined by the attending physician.Main outcomesPrimary outcome Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28 Secondary outcomes (followed until day 28). Time to respiratory deterioration Incidence of patients requiring mechanical ventilation: Number of days on mechanical ventilation Special emphasis will be placed on observing the following serious adverse events Deterioration of the glycemic profile that requires the use of insulin Delirium Incidence of hospital infections (pneumonia, urinary tract infection, device associated infections) Cumulative incidence of grade 3 and 4 adverse events (AE). Interruption or temporary suspension of treatment for any reason RANDOMISATION: Randomisation in permuted block. Computer generated random numbers in an allocation rate of 1:1. Stata 14.0 was used. Allocated by the principal investigator (direct communication).Blinding (masking)Patients not blinded. Caregivers not blinded. Participants not blinded. Statistician will not know the allocation.Numbers to be randomised (sample size)92 patients in each arm. 184 total number of patients.Trial statusProtocol version 2.0., approved October 2, 2020. Trial ongoing. Recruitment start: June 23, 2020. Anticipate finish recruiting: November 30, 2020. The protocol has been submitted before the last patient and last visit. The delay in sending to publication is responsibility of the authors.Trial registrationEarly Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID). Registration number NCT04451174 . Date of trial registration: June 26, 2020.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Dataset Information

Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial.

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