NCT04444271

Brief Summary

Since the outbreak of coronavirusdisease2019(COVID-19), many researchers in China have carried out/published clinical trials on treatment based on Western medicine, traditional Chinese medicine or a combination of the two. Trials on treatment modalities have mainly used antivirals, interferon, glucocorticoids in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline/chloroquine sulphate, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small (median sample size 100) and the bulk of potential therapeutic strategies remain in the experimental phase and currently there is no effective specific antiviral with high-level evidence.The aim of this study is assess the efficacy of MSCs as an add-on therapy to standard supportive treatment for patients with moderate/severe COVID-19.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

May 27, 2020

Last Update Submit

June 27, 2020

Conditions

COVID-19

Keywords

CoronavirusMesenchymal Stem CellsSurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Assessment of Overall survival at 30 days post intervention

    30 days post intervention

Secondary Outcomes (4)

  • Clinical improvement

    30 days

  • Time of COVID19 PCR negativity

    day 1,3,7,10, 14

  • Radiological improvement (day 15 and day 30 assessment)

    day 15 and day30

  • days required to discharge from hospital

    30 days post admission

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

10 patients will be given mesenchymal stem cells at dose 2x10\^6 cells/kg MSCs on days 1 and day 7 (if needed) in addition to standard care

Drug: Mesenchymal stem cells

Placebo

PLACEBO COMPARATOR

Only supportive care will be given to 10 patients

Other: Placebo

Interventions

Mesenchymal stem cellsDRUG

1\. Frozen MSCs will be resuspended in 100ml normal saline for immediate use and given intravenously. The patients should be pre-medicated to avoid allergic reactions to third party MSCs. Each patient in Experimental arm will be given 2 x 106 cells/kg will be administered on day 1,7 in addition to supportive care

Also known as: MSCs
Mesenchymal stem cells
PlaceboOTHER

100 ml of normal saline will be given intravenously to control arm

Placebo

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged ≥ 10years
  • Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
  • Moderate illness: In compliance with the 2019-coronavirus pneumonia diagnosis standard \[according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and world health organization (WHO) 2019 new coronavirus guidelines standards\]: (A) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation ≤93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
  • Critically ill : Respiratory failure, Septic Shock, muti-organ dysfunction syndrome (MODS)

You may not qualify if:

  • Patients with systemic autoimmune diseases
  • Not consenting for clinical trial
  • Those declared not for resuscitation due to underlying comorbid or current critical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIBMT

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • xanab akram

    NIBMT

    STUDY CHAIR

Central Study Contacts

xanab akram

CONTACT

03325346564xanab.akram@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research officer

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 23, 2020

Study Start

May 1, 2020

Primary Completion

August 30, 2020

Study Completion

September 30, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)