COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04621123

Oriol Mitjà Villar, PhD, MD

omitja@flsida.org

2020-11-09

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 1. adult male or female individuals of ≥50 years old. 2. in women of childbearing potential1, negative pregnancy test at inclusion/baseline. 3. has confirmed sars-cov-2 infection as determined by pcr or validated antigen rapid diagnostic test2 from nasopharyngeal swabs ≤5 days prior to inclusion/baseline visit. 4. symptomatic with mild or moderate covid-19 with symptoms onset date ≤ 7 days prior to inclusion/baseline visit. a. mild covid-19: individuals who have any of the common signs and/or symptoms of covid-19 (i.e., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnoea, or abnormal chest imaging. moderate covid-19: individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (spo2) ≥94% on room air at sea level. 5. willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. 6. has understood the information provided and capable of giving informed consent. 1 a woman will be considered of childbearing potential if not permanently sterilized nor postmenopausal. permanent sterilization methods include tubal ligation, hysterectomy and bilateral oophorectomy. postmenopausal is defined as 12 months with no menses without an alternative medical cause. 2 panbiotm covid-19 ag rapid test (abbott), standardtm q covid-19 ag test (roche) or any other ce marketed test for sars-cov-2 ag detection.

if female, pregnant, breastfeeding, or planning a pregnancy during the study. severe or critical covid-19: severe covid-19: respiratory frequency >30 breaths per minute, spo2 <94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300 mmhg, or lung infiltrates >50%. critical covid-19: respiratory failure, septic shock, and/or multiple organ dysfunction. current hospital admission for any cause. history of previous confirmed sars-cov-2 infection. history of significantly abnormal liver function (child pugh c). history of chronic kidney disease (ckd) ≥ stage 4, or need of dialysis treatment. any pre-existing condition that increases risk of thrombosis. history of allergic reactions to blood or plasma products or methylene blue. known iga deficiency with anti-iga antibodies. medical conditions for which 300ml of intravenous fluid is considered dangerous (i.e., decompensated heart failure or renal failure with fluid overload). inability to consent and/or comply with study requirements, in the opinion of the investigator. currently participating or planning to participate in any interventional study for the treatment of covid-19 or sars-cov-2 infection until day 60.

2

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

50

100

Spain

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

384

SARS-CoV-2 viral load (safety and efficacy);Hospitalization rate (safety and efficacy)

None

Phase 2

[{"arm_notes": "", "treatment_id": 321, "treatment_name": "Convalescent anti-sars-cov-2 methylene blue treated (mbt) plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]