Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Plasma From Patients Cured of COVID-19 Compared to the Best Available Therapy in Subjects With SARS-CoV-2 Pneumonia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronavirus Infection
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Early all-cause mortality
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern.
According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown.
Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19.
The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.
Detailed Description
Randomized clinical trial comparing convalescent plasma to best available therapy (BAT) for the treatment of severely ill and critically ill patient with COVID-19: Patients will be electronically randomized 2:1 (plasma vs BAT) in a double blind fashion. Patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Primary outcomes will be early all-cause mortality, and secondary outcomes will include all cause in hospital mortality, length of mechanical ventilation and hospital stay, time to PAO2 \>200, progression of pulmonary infiltrates, antibody titers and time to negative PCR detection
Investigators
Dr. Adrian Camacho-Ortiz
Head of the Infectious Disease Department
Hospital Universitario Dr. Jose E. Gonzalez
Eligibility Criteria
Inclusion Criteria
- •Men or women ≥18 years. If you are a woman of childbearing age, you must agree to practice abstinence or to use an effective method of contraception during the study period.
- •Vascular access suitable for administration of hemocomponents.
- •SARS-CoV-2 positive RT-PCR.
- •Negative pregnancy test in case of a woman of reproductive age
- •Signing of evidentiary document of informed consent.
- •Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
- •Subjects who access the storage of biological samples for future examination.
Exclusion Criteria
- •Respiratory rate \>30 RPM, SO2 \<93%, PaO2/FiO2 \<200 despite intervention with oxygen therapy after 60 minutes of hospitalization.
- •New alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital.
- •PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- •Pregnant or breastfeeding patients.
- •Patients that the investigators consider inappropriate to participate in the clinical trial
- •Contraindication to transfusion or history of previous severe reaction to blood products.
- •Have received any blood products in the last 120 days.
Outcomes
Primary Outcomes
Early all-cause mortality
Time Frame: 14 days
any cause mortality during the first 14 days of treatment
Secondary Outcomes
- Time in days for SARS-CoV-2 RT-PCR negatives(90 days)
- Detection of serum antibodies(days 0, 3, 7, 14 and 90.)
- The serum anti-SARS-CoV-2 antibody titres(90 days)