First Wave BioPharma, Inc. announced that an independent data monitoring committee (DMC) has recommended that enrollment continue in Part 2 of the ongoing RESERVOIR Phase 2 trial evaluating FW-COV as a treatment for COVID-19-related?gastrointestinal (GI) infections. FW-COV is a proprietary, oral, tablet formulation of micronized niclosamide developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract. The DMC recommendation was based on its review of the safety data collected from the first 25 patients enrolled in Part 2 of the RESERVOIR trial. The review of the data uncovered no safety issues. Part 2 of the study will enroll up to 150 patients. RESERVOIR is designed as a two-part, two-arm, randomized, placebo-controlled Phase 2 study with a primary purpose to confirm the safety of FW-COV and assess the drug?s ability to remove the SARS-CoV-2 (SARS2) virus from the digestive tract. Patients enrolled in Part 2 of the study are randomized to receive either niclosamide or a placebo treatment for 14 days. After 14 days, patients will cease treatment but remain under observation for up to six weeks, with additional follow-up observations at 4 month and 6-months to assess persistence or recurrence of symptoms. The efficacy of FW-COV is measured by the rate of SARS2 clearance from stool samples assessed by PCR test, comparing the niclosamide arm and the placebo arm. Long-term observation could indicate whether niclosamide treatment has the potential to prevent ?long haul? COVID-19 symptoms.