UnknownPhase 2

A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection

Israel155 participantsStarted 2021-07-11

Plain-language summary

A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent. 155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days. Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
. Age 18-80 years
. Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):
. Willing and able to sign an informed consent

Exclusion criteria

. Age\<18 years or \>80 years
. Any concomitant illness that, based on the judgment of the Investigator is terminal

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease

Timeframe: One year

To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease

Timeframe: One year

To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.

Timeframe: One year

To evaluate the death rate.

Timeframe: One year

To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).

Timeframe: One year

To evaluate time from hospitalization to hospital discharge.

Timeframe: One year

To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.

Timeframe: One year

Trial details

NCT IDNCT04969172

SponsorEli Sprecher, MD

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-07-11

View on ClinicalTrials.gov More COVID-19 Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
. Age 18-80 years
. Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):
. Willing and able to sign an informed consent

Exclusion criteria

. Age\<18 years or \>80 years
. Any concomitant illness that, based on the judgment of the Investigator is terminal

What they're measuring

To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease

Timeframe: One year

To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease

Timeframe: One year

To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.

Timeframe: One year

To evaluate the death rate.

Timeframe: One year

To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).

Timeframe: One year

To evaluate time from hospitalization to hospital discharge.

Timeframe: One year

To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.

Timeframe: One year