Trials Sponsors Conditions Drugs Pricing

Conditions

COVID-19 SARS-CoV-2 PNEUMONIA

Keywords

Covid-19SARS-CoV-2exosomesMSC

Outcome Measures

Primary Outcomes (2)

Number of participants with non-serious and serious adverse events during trial
Safety assessment such as adverse events will be registered. Adverse events will be monitored during all trial
through study, an average of 2 months
Number of participants with non-serious and serious adverse during inhalation procedure
Safety assessments such as adverse events during the inhalation procedures will be registered.
10 days during inhalation procedures

Secondary Outcomes (8)

Time to clinical recovery (TTCR)
up to 2 months
SpO2 concentration changes
up to 2 months
Chest Imaging Changes
Three times. At diagnosis, 10-14 days after treatment and 30 days after clinic discharge
Blood biochemistry (CRP)
Baseline, day 5, 10, 20
Procalcitonin concentration
Baseline, day 5, 10, 20
+3 more secondary outcomes

Study Arms (3)

EXO-1

EXPERIMENTAL

Participants (n=30) in this group will receive standard therapy and exosomes of the first type.

Drug: EXO 1 inhalation

EXO-2

EXPERIMENTAL

Participants (n=30) in this group will receive standard therapy and exosomes of the second type.

Drug: EXO 2 inhalation

Placebo

PLACEBO COMPARATOR

Participants (n=30) in this group will receive standard therapy and inhalation placebo solution.

Interventions

EXO 1 inhalationDrug

Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.

EXO-1

EXO 2 inhalationDrug

Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.

EXO-2

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability to understand the study objectives and risks and provide signed and dated informed consent;
COVID-19 infection (by PCR or antibody test or high probability of COVID-19 by CT);

Sponsors & Collaborators

Olga Tyumina
Otherlead
Samara Regional Clinical Hospital V.D. Seredavin
Othercollaborator
Samara State Medical University

Study Sites (1)

Medical Centre Dinasty

Samara, 443095, Russia

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, CARE PROVIDER
Masking Details: Two main groups will be provided with exosomes in a specially provided solution, the third group (control) will receive the same solution without exosomes. Due to exosomes are nanoparticles and requires special methods and devices to be detected the hospital staff and patients have no way to check which group receives exosomes.
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Director

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 26, 2020

Study Start

You may not qualify if:

Severe respiratory failure at the time of screening due to COVID-19 pneumonia;
Known to undergo medical resuscitation for 14 days before randomization;
Any serious medical condition or deviation of the clinical laboratory parameter that, in the opinion of the researcher, prevents safe participation and completion of the study by the participant Confirmed uncontrolled active bacterial, fungal, viral or other infection (other than SARS-CoV-2).
According to the researcher, the progression to death is inevitable and will occur within the next 24 hours, regardless of the therapy.
The life expectancy of fewer than 28 days, taking into account a medical condition already existing that cannot be corrected, e.g. participants with the following conditions or suspicions: polyorganic insufficiency, poorly controlled neoplasms, terminal stage heart disease, cardiopulmonary cardiac arrest that required cardiopulmonary resuscitation, or electrical activity not accompanied by a pulse, or asystole within the last 30 days, terminal stage liver disease, terminal stage liver disease, or liver disease;
Pregnancy or breastfeeding;
Liver function failure (Class C for Child-Pugh), detected within 24 hours at screening (local laboratory);
Absolute neutrophil count (ANC) \<500 cells/µL at screening (local laboratory);
Platelet count \<50000 cells/µL at screening (based on laboratory data);
Creatinine level ≥ 1.5 from the upper limit;
Uncontrolled or untreated arrhythmia with clinical manifestations, myocardial infarction within the last 6 weeks or congestive heart failure (NYHA Degrees 3 or 4);
Respiratory failure in the last 6 months or home use of oxygen in severe chronic respiratory disease (COPD);
Quadriplegia;
Primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy, aspergillosis or other invasive mold/fungal infection in anamnesis, or internal or bone marrow transplantation for 6 months before randomization;
Known infection with hepatitis B or C viruses requiring therapy;

Safety and Efficiency of Method of Exosome Inhalation in COVID-19 Associated Pneumonia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (3)

EXO-1

EXO-2

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (3)

EXO-1

EXO-2

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations