COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04362189

Rajiv Thakur, MD

Katherine Ruppert, katie@hopebio.org (PI email not reported)

2020-04-24

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: men, and women, over 18 years of age inclusively. patient is suspected to have covid-19 infection. provides consent or consent is given by their legally authorized representative (lar). agrees to the collection of venous blood per protocol. women of childbearing potential (wocbp) and men (if their sexual partners are wocbp) must use at least 1 highly effective form of birth control throughout the study and for 6 months after the last dose of study treatment. highly effective methods of birth control include true sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk, in line with the preferred and usual lifestyle of the patient), surgery (bilateral tubal ligation or occlusion, vasectomized partner), progestogen-only or estrogen/progestogen hormonal contraceptive associated with inhibition of ovulation (oral, patch, injectable, implantable, or intravaginal), intrauterine device (iud), or intrauterine hormone-releasing system (ius).

pregnancy, lactation and those who are not pregnant but do not take effective contraceptive measures, in women of childbearing age. absence of pregnancy will be confirmed through urine pregnancy test. patients who have participated or are participating in a clinical trial of an experimental vaccine for sars-cov-2 or coronavirus during the study or within 30 days. inability to provide informed consent or to comply with study requirements. patients with the following concomitant or past medical history: both hypertension and diabetes mellitus. both hypertension and chronic kidney disease. both diabetes mellitus and chronic kidney disease. history or evidence of alcohol abuse. history or evidence of consumption of illicit drugs. patients requiring mechanical ventilation. patients who are determined by the principal investigator to be unsuitable for study enrollment for other reasons. any medical disease or condition that, in the opinion of the site principal investigator or sub-investigator, precludes study participation. including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.

2

Hope Biosciences Stem Cell Research Foundation

2

100

United States

No restriction on type of patients

0: No restriction on type of patients

48

C-Reactive Protein (CRP);Interleukin-10 (IL-10);Interleukin-6 (IL-6);Oxygenation;Return To Room Air (RTRA);Tumor Necrosis Factor-Alpha (TNF-alpha)

None

Phase 2

[{"arm_notes": "", "treatment_id": 587, "treatment_name": "Hope biosciences allogeneic mesenchymal stem cell therapy (hb-admscs)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]