NCT04916574

Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

Completed NA Last updated 9 June 2021

What this trial tests

NA trial testing Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum in SARS-COV2 Infection in 16 participants. Completed in 3 June 2021.

Timeline

20 March 2021

Primary endpoint
28 March 2021

3 June 2021

Quick facts

Lead sponsor	Icosagen Cell Factory
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	16
Start date	20 March 2021
Primary completion	28 March 2021
Estimated completion	3 June 2021
Sites	1 location across Estonia

Drugs / interventions tested

• Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum

Conditions studied

• SARS-COV2 Infection — all drugs for SARS-COV2 Infection →
• Covid19 — all drugs for Covid19 →

Sponsor

Icosagen Cell Factory

Who can join

Adults 18 to 80, any sex, with SARS-COV2 Infection or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. A "first-in-man" clinical study of the nasal spray containing anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. In addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. The volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. The concentration of antibodies from patient samples was measured using ELISA analysis. In addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants.
   Strohl WR, Ku Z, An Z, Carroll SF, et al · · 2022 · cited 31× · PMID 35476216 · DOI 10.1007/s40259-022-00529-7
2. Bovine colostrum-derived antibodies against SARS-CoV-2 show great potential to serve as prophylactic agents.
   Kangro K, Kurašin M, Gildemann K, Sankovski E, et al · · 2022 · cited 15× · PMID 35687549 · DOI 10.1371/journal.pone.0268806
3. Bovine Colostrum Derived Antibodies Against SARS-CoV-2 Show Great Potential to Serve as a Prophylactic Agent
   Kangro K, Kurašin M, Gildemann K, Sankovski E, et al · · 2021 · cited 1× · DOI 10.1101/2021.06.08.21258069