Trial NCT04457609
Publication Dilogo IH, Stem Cells Transl Me (2021) (published paper)
Dates: 2020-05-01 to 2020-10-10
Funding: Public/non profit (Ministry of Research and Technology/National Research and Innovation Agency Republic of Indonesia.)
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Multicenter / Indonesia
Follow-up duration (days): *
Inclusion criteria
  • 18-95 years
  • critically ill patients
  • intubated
  • severe pneumonia
  • pneumonia on chest x-ray and/or ground-glass opacity on thorax computed tomography (CT) scan
  • postive RT-PCR bronchoalveolar lavage
  • respiratory failure that progressed into ARDS, defined as the partial pressure of oxygen in arterial blood(PaO2)/the fraction of inspired oxygen (FiO2) lower than 300 mmHg
  • supported by mechanical ventilation
  • shock, such as septic shock (persistent hypotension following fluid resuscitation and requiring vasopressor to maintain mean arterial pressure of ≥65 mmHg and serum lactate of >2 mmol/L)
  • multiple organ failure and monitored in the ICU
  • leukopenia and lymphopenia in peripheral blood and differential count
  • informed consent by subjects or family members
Exclusion criteria
  • History of malignancy
  • pregnant or showed a positive pregnancy test
  • history of or currently taking part in another clinical trial in the last 3 months
Interventions
Treatment
UC-MSC
1*10^6/kg IV, once-off
Control
Placebo

Participants
Randomized
participants :
Placebo=20
UC-MSC=20
Characteristics of participants
N= 40
Mean age : NR
30 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=40
Number of vaccinated participants: NR
Primary outcome
In the register
Clinical improvement:Presence of dyspnea, presence of sputum, fever, ventilation status, blood pressure, heart rate, respiratory rate, oxygen saturation [Time Frame: 15 days]
In the report
mortality rate and length of ventilator usage
Documents
available

Protocol

Yes. In English

Statistical plan

NR

Data-sharing willing stated in the publication:

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
*
General comment This study is pending author reply. Time points outcomes were not clearly reported.

In addition to the available version of the publication, the study registry and protocol were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does not reflect the reported primary outcome. Some outcomes from the registry are not reported in the paper (e.g. clincal improvement).Some outcomes (e.g. mortality) are reported in the paper, but were not pre-specified in the trial registry. In the registry, the primary outcome is clinical improvement in the presence of dyspnea, presence of sputum, fever, ventilation status, blood pressure, heart rate, respiratory rate, and oxygen saturation. The follow-up time of study participants is unclear.