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convalescent plasma treatment (n=150) vs. placebo (n=73)
randomized controlled trial
Convalescent plasma
Single unit of plasma (~200-250 milliliters) transfused over approximately 2 hours.
Normal control plasma
Single unit of plasma (~200-250 milliliters) transfused over approximately 2 hours.
Convalescent plasma collected from patients who had recovered from laboratory-confirmed COVID-19 with a minimum anti-SARS-CoV-2 total IgG antibody titer of ≥1:400. Control plasma consisted of oldest available plasma at each study site without prior testing for anti-SARS-CoV-2 antibodies and collected prior to January 1st, 2020 in Rio de Janeiro and February 20th, 2020 in New York City.
COVID-19 severe or critically
Hospitalized patients aged ≥18 years with laboratory-confirmed COVID-19, infiltrates on chest imaging and oxygen saturation ≤ 94% on room air or requirement for supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation
Double-blind.
5 hospitals in New York City, USA and Rio de Janeiro, Brazil.
The primary outcome was measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population. The ordinal scale is based on that recommended by the World Health Organization : 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation; 6, hospitalized, requiring ECMO, IMV, or both; 7, death.
Phase II.
convalescent plasma treatment (n=228) vs. placebo (n=106)
randomized controlled trial
Convalescent plasma
Single administration of Covid-19 convalescent plasma in addition to standard treatment. The convalescent plasma infused volume was defined within the range of 5-10 ml/kg with aninferior limit around 400 ml for patients whose body weight was below 70 kg and a superior limitof 600 ml for those above 70 kg.
Placebo
Single dose of normal saline solution in addition to standard treatment.
2:1 ratio. Patients were allowed to receive antiviral agents, glucocorticoids, or both according to the standard of care at the provider health care institution.
COVID-19 severe or critically
Reverse-transcriptase–polymerase-chain-reaction (RT-PCR) positive for SARS-CoV-2, radiologically confirmed pneumonia, no previous directives rejecting advanced life support, and at least one of the following severity criteria: oxygen saturation (SaO2) below 93% while they were at rest and breathing ambient air, a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) below 300 mm Hg (PaO2 :FiO2), or a Sequential Organ Failure Assessment (SOFA) or modified SOFA (mSOFA) score of two or more points above baseline status.
Double blind.
12 clinical sites in Argentina (coordinated by Hospital Italiano de Buenos Aires).
Adapted version of the World Health Organization (WHO) clinical scale: 1 indicated death, 2 invasive ventilatory support, 3 hospitalized with supplemental oxygen requirement, 4 hospitalized without supplemental oxygen requirement, 5 discharged without full return to baseline physicalfunction, and 6 discharged with full return to baseline physical function.
convalescent plasma treatment (n=52) vs. standard of care (n=51)
randomized controlled trial
Convalescent plasma
Thetransfusion dose of COVID-19 convalescent plasma was approximately 4 to 13 mL/kg of recipient bodyweight. Convalescent plasma transfusion was administered at approximately 10mLfor the first 15 minutes, which was then increased to approximately 100 mL per hour with close monitoring.
standard treatment alone.
Standard treatment consisted of symptomatic control and supportive care for COVID-19, mostly based on the evolving Chinese national COVID-19 treatment guidelines and hospital practice. Possible treatments included antiviral medications, antibacterial medications, steroids, human immunoglobulin, Chinese herbal medicines, and other medications.
SoC in both groups.
COVID-19 severe or critically
Open-label
7 medical centers in Wuhan, China,
Clinical improvement defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]).
convalescent plasma treatment (n=1095) vs. standard of care (n=916)
randomized controlled trial
Convalescent plasma
High-titer ABO compatible convalescent plasma (total volume approximately 550 /- 150 ml) within 48 hours of randomization
Standard of care
COVID-19 severe or critically
REMAP-CAP exclusion criteria included presumption that death was imminent with lack of commitment to full support, or participation in REMAP-CAP in the prior 90 days.
Open-label.
129 sites in UK, Australia, US, Canada.
In this composite ordinal outcome, all deaths within the hospital, up to day 90, are assigned the worst outcome (–1 day). Among survivors, respiratory and cardiovascular organ support-free days were calculated up to day 21, such that a higher number represents faster recovery.
The convalescent plasma intervention was stopped after pre-specified criteria for futility were met.
convalescent plasma treatment (n=21) vs. standard of care (n=28)
randomized controlled trial
Convalescent plasma
400 mL of frozen convalescent plasma transfused over 2 hours, The convalescent plasma was given only once for all of the patients in the CP group.
Standard of care
Included patients, whether in CP or control group, were exactly on the same protocol of therapy: hydroxychloquine 200 mg twice per day for at least 10 days plus azithromycin once 500 mg/day loading dose, followed by 250mg once per day for 5 days plus oxygen therapy plus methylprednisolone 40 mg per day after admissionto RCU.
COVID-19 severe or critically
Adult patients ≥18, with SpO2 <90% in resting state, affected by pneumonia at their first 3 days in RCU receiving O2 or on ventilators.
Open-label.
Multicenter, 3 hospitals in Baghdad, Iraq.
Recovery or death, length of stay inhospital, and improvement in the clinical course ofthe disease were monitored clinically.
convalescent plasma treatment (n=43) vs. standard of care (n=47)
randomized controlled trial
A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition.
COVID-19 severe or critically
Open-label.
Germany.
Study not published yet. Results and risk of bias assessment were extracted from Axfors C. et al meta-analysis https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06829-7?s=09.
convalescent plasma treatment (n=49) vs. standard of care (n=51)
randomized controlled trial
convalescent plasma hydroxychloroquine azithromycine
500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day. azithromycin (500 milligrams daily) and hydroxychloroquine (400 milligrams each 12 hours) for 10 days
hydroxychloroquine azithromycin
hydroxychloroquine 400 milligrams each 12 hours for 10 days ; azithromycin 500 milligrams daily for 10 days
COVID-19 severe or critically
open-label, randomized
3 centers, colombia
multiple testing estimated enrollment : 80 participants
convalescent plasma treatment (n=31) vs. standard of care (n=31)
randomized controlled trial
Convalescent plasma
One unit (500 mL) plasma on the admission day plus standard drugs. The first plasma unit was injected in the first 4 h after admission; according to the physician’s recommendation, the second unit was prescribed if no improvement was observed after 24 h.
Standard of care
Five patients required the administration of the second unit of plasma. All patients received similar antiviral therapy, including Ritonavir/Lopinavir, and chloroquine phosphate.
COVID-19 severe or critically
1- COVID-19 patients who had specifed COVID-19 symptoms (less than 7 days since the onset of the symptoms).2- The positive results of PCR test and CT scan.3- Severity WHO score>4.4- Blood oxygen saturation (SPO2) ≤93% in room air. 5- Individuals who no exhibit hypersensitivity to plasma intravenous administration.6- Those who voluntarily signed the informed consent.
Single-blind.
Single center: emergency departement in Razi hospital of Ahvaz, Iran.
In the register, primary endpoints were: Complete remission of clinical signs, negative qRT-PCR test, and improved CT scan. (7-14 days after starting the treatment).
convalescent plasma treatment (n=53) vs. standard of care (n=52)
randomized controlled trial
Convalescent plasma
3 units of CCP: The administration of CCP should commence within 1 day after randomization, one transfusion unit each of CCP was given on day 1, 3 and 5.
Standard of care
Standard treatment alone.
Seven patients randomized to the control group crossed over to receive CCP after assessment on day 14 because of progressive COVID-19 (failure of primary outcome). Patients in the crossover group also received one unit of CCP on three days. Patients in both groups received other anti-viral treatment and/or supportive treatment according to institutional standard procedures.
COVID-19 severe or critically
(1) SARS CoV-2 infection confirmed by PCR (bronchoalveolar lavage, sputum, nasal and/or pharyngeal swap); (2) age ≥ 18 years and ≤ 75 years and (3) severe disease defined by at least one of the following: a)respiratory rate ≥ 30 breaths / minute under ambient air; b) requirement of any type of ventilation support (defined as supplemental oxygen or non-invasive ventilation or invasive ventilation or ECMO); c) needs treatment on ICU; (4) written informed consent by patient or representative.
Open-label.
Multicenter, 13 hospitals in Germany.
convalescent plasma treatment (n=80) vs. standard of care (n=80)
randomized controlled trial
Convalescent plasma
Two infusions 48 hours apart of 300ml of CP plus Standard of Care (SOC).
Standard of care
Standard of care alone.
All patients in both groups received standard of care. The SOC for COVID-19 was at the discretion of the treating physicians. The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed. Remdesivir was not available in Brazil during the trial period.
COVID-19 severe or critically
18 or older, positive reverse transcriptase polymerase chain reaction (RT-PCR) for SARSCoV-2, less than 15 days of initial symptoms onset, and severe respiratory disease, as defined by the presence of at least one of the following: respiratory rate >30 breaths per minute in room air; oxygen saturation (O2) ≤93% in room air; arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 300; need for supplemental O2 to maintain O2 saturation >95%; need for supplemental O2 by high flow nasal cannula, non-invasive ventilation, or invasive mechanical ventilation.
Open-label.
Single center: single COVID-19 reference hospital, Porto Alegre, Brazil.
Clinical improvement was defined as hospital discharge or reduction of 2 points in a 6-level ordinal scale defined as follows; 1, not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation or extracorporeal membrane oxygenation; and 6, death.
One pre-planned interim analysis for efficacy and safety evaluation after 80 patients with complete follow-up was conducted. The stopping rule for efficacy and safety was a P value<.05. There was no adjustment in the final threshold for statistical significance for sequential analysis.
convalescent plasma treatment (n=20) vs. standard of care (n=20)
randomized controlled trial
Convalescent plasma
400 mL of CP, given as 200ml over 2hrs over 2 successive days; the infusion rate was monitored and amended if there was a risk of fluid overload.
Standard of care
The standard supportive treatment included control of fever (paracetamol) and possible therapy including antiviral medications, Tocilizumab and antibacterial medication.
Patients prior to CP therapy were on standard supportive treatment including control of fever (paracetamol) and possible therapy including antiviral medications, Tocilizumab and antibacterial medication.
COVID-19 severe or critically
Patients with COVID-19 diagnosis based on polymerase chain reaction (PCR) testing, hypoxia (Oxygen saturation of less than or equal 92% on air, or PO2 < 60mmHg in arterial blood gas, or arterial partial pressure of oxygen (PaO )/fraction of inspired oxygen (FIO) of 300 or less) and patient requiring oxygen therapy, pneumonia confirmed by chest imaging. Patients requiring ventilatory support (invasive or non-invasive) were excluded.
Open-label.
Two medical centres in Bahrain.
Pilot trial.
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