A Phase 1/2 interventional study of V-SARS in Covid19, sponsored by Immunitor LLC. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Immunitor LLC · Phase 1/2, Interventional, and Treatment
Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.
Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 20 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm having at least 20 volunteers administered once-per-day pill of V-SARS
Biological: V-SARS
Therapeutic vaccine formulated as a pill derived from heat-inactivated plasma from COVID-19 patients administered once-per-day to at least 20 healthy volunters for at least one month
Effect on CBC as per CTCAE v4.0
Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods
Time frame: 15 Days
Effect on biochemistry parameters as per CTCAE v4.0
Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
Time frame: 15 Days
Lack of adverse events as per CTCAE v4.0
Clinical well-being assessed by CTCAE v4.0
Time frame: 15 days
Plan to share: Yes — Free dissemination of published data
Supporting information: Study protocol
Time frame: when become public
Access criteria: non-confidential data
Data sharing details ↗ · immunitor.com
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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