Clinical trial NCT04514302: Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19
Official title: Phase I, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Antiviral Efficacy of Three Different Single Doses of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) in Adult Patients With Mild COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
Immunoglobulin fragments
Hyperimmune equine serum
Passive immunotherapy
Lead sponsor: TecSalud Investigación Clínica
Sponsor class: OTHER
Collaborators: name: Inosan Biopharma
First posted: 2020-08-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion criteria

* Outpatient with a RT-qPCR confirmation of SARS-CoV-2 infection
* Body Mass Index (BMI) at screening of 18.0 - 34.9 kg/m\^2
* Presence of at least one symptom consistent with COVID-19
* Mild illness as defined by no requirement of supplementary oxygen or hospitalization criteria are met

Key Exclusion criteria

* Presence of a risk factor for disease progression documented for COVID-19 such as: uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease, pulmonary disease, COPD, asthma, active cancer, immunosuppression, hypercoagulable states, CKD currently under dialysis
* Documented allergy to equine serum proteins
* Previous hospitalization due to COVID-19
* Supplementary oxygen, invasive ventilation, or mechanical circulatory support requirements
* Having received convalescent plasma or intravenous immunoglobulins for the treatment of COVID-19
* Previous vaccination or plans to get vaccinated for COVID-19
* In the opinion of investigator, other health conditions that suppose an increased risk of progression of disease

NOTE: Other inclusion/exclusion criteria apply

Primary outcomes:
measure: Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples
timeFrame: Baseline to days 2, 4, 7, 14 and 28
measure: Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples
timeFrame: At days 2, 4, 7, 14 and 28
measure: Time of viral activity
timeFrame: Baseline to 28 days
Secondary outcomes:
measure: Adverse events presented early after infusion
timeFrame: Baseline to 24 hrs
measure: Adverse events presented later after infusion
timeFrame: Day 2 until day 28
measure: Incidence of anti-INOSARS antibodies
timeFrame: Baseline and day 28
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital San José, Tec de Monterrey
state: Nuevo Leon
Study officials:
affiliation: TecSalud Investigación Clínica
name: José F Castilleja-Leal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.