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| Name | Class |
|---|---|
| Inosan Biopharma | INDUSTRY |
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This is a randomized, placebo-controlled, double-blind phase I clinical study of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) to evaluate the safety and antiviral efficacy for the treatment of adult patients with mild COVID-19 and low risk of disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min. |
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| INOSARS dose 1 | Experimental | Single dose of 5 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min. |
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| INOSARS dose 2 | Experimental | Single dose of 15 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min. |
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| INOSARS dose 3 | Experimental | Single dose of 30 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples | Baseline to days 2, 4, 7, 14 and 28 | |
| Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples | At days 2, 4, 7, 14 and 28 | |
| Time of viral activity | Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples | Baseline to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events presented early after infusion | Number of adverse events per group presented in the first 24 hours | Baseline to 24 hrs |
| Adverse events presented later after infusion | Number of adverse events per group presented 24 hours past infusion |
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Key Inclusion criteria
Key Exclusion criteria
NOTE: Other inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| José F Castilleja-Leal, MD | TecSalud Investigación ClÃnica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San José, Tec de Monterrey | Monterrey | Nuevo León | 64718 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32445440 | Background | Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8. |
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Parallel
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Double Blind
| Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) | Drug | INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content. |
|
|
| Day 2 until day 28 |
| Incidence of anti-INOSARS antibodies | Baseline and day 28 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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