Trial NCT04473170
Publication Ventura-Carmenate Y, Transl Med Commun, 2021 (published paper)
Dates: 2020-04-04 to 2020-07-31
Funding: Private (Abu Dhabi Stem Cells Center )
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / United Arab Emirates
Follow-up duration (days): 28
Inclusion criteriaReal-Time Polymerase Chain Reaction (RTPCR) Laboratory confirmation of COVID-19; male or female aged ≥18 years; Hospitalized and symptomatic patients, referring one or more of the following symptoms (fever, cough, or shortness of breath), in association with (at least one): tiredness, runny nose, headache, sore throat, chills, muscle pain, or new loss of taste or smell; Ability to comply with test requirements and for peripheral blood stem cells collection.
Exclusion criteriaPediatric patients (aged < 18 years); Diagnosis of any shock; Organ transplants in the past 3 months; Patients receiving immunosuppressive therapy; Diagnostic of Hepatitis B Virus (HBV) infection; Diagnostic of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS); Current diagnosis of cancer; History of malignancies in the past 5 years; Pregnant or lactating women; Having participated in other clinical trials in the past 3 months; Inability to provide informed consent.
Interventions
Treatment
Standard care
*
Control
Autologous Non-Hematopoietic Peripheral Blood Stem Cells ( / )
Participants
Randomized
143 participants (n1=72 / n2= 71)
Characteristics of participants
N=143
Mean age : 45.1
129 males
Severity : Mild: n=77 / Moderate: n=18/ Severe: n=10 Critical: n=34
Primary outcome
In the register
Adverse reactions incidence. [ Time Frame: Day 0 - 28 ]; Rate of mortality within 28-days. [ Time Frame: Day 0 - 28 ]; Time to clinical improvement on a seven-category ordinal scale. [ Time Frame: Day 0 - 28 ]
In the report
a) Hospital discharge. Assessed after the first 9 days of randomization: (1st. tertile of the follow-up); b) Mortality. Death by any cause in the 28 days of follow-up.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the pre-print article and the retrospective registry were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The study achieved its target sample size.
The study was updated on the December 8th, 2021 with data from the journal publication.