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Drug Development and Delivery ; 22(4):18-23, 2022.
Article in English | Scopus | ID: covidwho-2012508
NTIS; 2020.
Non-conventional in English | NTIS | ID: grc-753748


Regulatory approvals - US Food and Drug Administration, USAMRMC Human Research Protections Office (HRPO), Health Canada - have been completed for 14 participating sites. Remaining 3sites are poised for approval during Q1 of year 4. 14 of the participating sites have received ethics approval. Site initiation visits were completed at 6 sites, with 11 actively recruiting before COVID-19 lockdown. Bay Area Research Logistics (BARL) has completed shipment of medication to 11 sites, with plans on shipping medication to 3 more sites duringQ1 or year 4. These efforts have led to active sites successfully recruiting and randomizing51 participants. Screening/recruitment efforts have been limited due to COVID-19 restrictions at all sites of interest. Only 6 sites have been approved for trial restart by the local operating officials. However, all sites with active participants were able to safely continue data collection efforts. Site contract negotiations have been completed at 16 sites, with the last remaining to be done during Q1 of Year 4. Bi-weekly safety summary meetings are being held with local Research Monitor to review AE/SAEs. Updated versions of charters for Data Monitoring Committee (DMC), Trial Steering Committee (TSC), and Trial Management Group (TMG)were finalized. Monthly TMG meetings are being held, with TSC meetings occurring every three months. DMC membership has been finalized, with plans of holding first meeting during Q1 of Year 4. One manuscript was published during this reporting period.

Viruses ; 13(4)2021 03 26.
Article in English | MEDLINE | ID: covidwho-1154534


The 2019 coronavirus infectious disease (COVID-19) is caused by infection with the new severe acute respiratory syndrome coronavirus (SARS-CoV-2). Currently, the treatment options for COVID-19 are limited. The purpose of the experiments presented here was to investigate the effectiveness of ketotifen, naproxen and indomethacin, alone or in combination, in reducing SARS-CoV-2 replication. In addition, the cytotoxicity of the drugs was evaluated. The findings showed that the combination of ketotifen with indomethacin (SJP-002C) or naproxen both reduce viral yield. Compared to ketotifen alone (60% inhibition at EC50), an increase in percentage inhibition of SARS-CoV-2 to 79%, 83% and 93% was found when co-administered with 25, 50 and 100 µM indomethacin, respectively. Compared to ketotifen alone, an increase in percentage inhibition of SARS-CoV-2 to 68%, 68% and 92% was found when co-administered with 25, 50 and 100 µM naproxen, respectively. For both drug combinations the observations suggest an additive or synergistic effect, compared to administering the drugs alone. No cytotoxic effects were observed for the administered dosages of ketotifen, naproxen, and indomethacin. Further research is warranted to investigate the efficacy of the combination of ketotifen with indomethacin (SJP-002C) or naproxen in the treatment of SARS-CoV-2 infection in humans.

Antiviral Agents/pharmacology , COVID-19/virology , Indomethacin/pharmacology , Ketotifen/pharmacology , Naproxen/pharmacology , SARS-CoV-2/drug effects , Cytopathogenic Effect, Viral/drug effects , Drug Evaluation, Preclinical , Drug Synergism , Drug Therapy, Combination , Humans , SARS-CoV-2/genetics , SARS-CoV-2/physiology , COVID-19 Drug Treatment