COVID-19 Clinical Trials and Expanded Access

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant fortreatment and to assess the potential in reducing mortality and morbidity rates inCOVID-19 patients. The study was approved by the ethical committee of the Egyptian Centerfor Research and Regenerative Medicine in 11-5-2020.

Antioxidants, and particularly polyphenols, have shown protection in respiratorypathologies, which is related to the decrease in the severity of the clinical picture andsuppression of inflammation. This suppression of inflammation may be related to theinhibition of NF-kB polyphenols, where its activation is related to the stimulation of150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others.There may be other additional mechanisms that can help control virus-induced respiratorypathologies, among which are the regulation of reactive oxygen species (ROS) associatedwith tissue destruction caused by the virus and a selective antiviral action can bereported. direct.The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of thePontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation andtissue damage and induces complete autophagy in stressed or tumor cells. The induction ofa full autophagic flow could inhibit the replication of beta-coronaviruses likeSARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage byreducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases(unpublished data).These antecedents suggest that the supplementation of patients with COVID-19 with theextract P2Et, could improve their general condition and decrease the inflammatorymediators and the viral load.

This study aims to find out whether the use of angiotensin II, which is a drug to raiseblood pressure has been approved by European Medical Agency in August 2019, as an add-onmedication to increase blood pressure in patients with COVID-19, acute severe lunginjury, inflammation and severe shock, compared with standard medication. In addition,the investigators will collect the data of Anakinra, another drug which is frequentlyused in this condition to reduce inflammation.The investigators will collect clinical data and outcomes from critical care patients.The investigators will analyse for whom these drugs are most beneficial and explorewhether there are any patients who don't benefit or have side effects.

This is a randomized double-blind placebo-controlled Phase II trial of recombinant humandeoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients withCOVID-19 pneumonia.Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanicalventilation will be invited to participate in this study. Potential subjects will beidentified from medical record review or from direct contact with physicians.Investigators will check medical history and confirm eligibility. Informed consent willbe obtained from either the patient or designated healthcare proxy.60 subjects will be enrolled. After obtaining informed consent, patients will berandomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longerreceiving mechanical ventilation, whichever is sooner plus standard of care vs. placebonormal saline 2.5 ml plus standard of care.

Primary care physicians face limited availability of therapeutic options for thetreatment of COVID-19 in the outpatient setting. Furthermore, monoclonal antibodies andantiviral therapies that are currently approved for use in the outpatient setting byHealth Canada have excluded pregnant women and older adults from their clinical trials,are contraindicated for many patients, and most are prohibited for use by pregnant women.Identification of a safe, COVID-19 outpatient therapeutic with 20-year safety recordremains urgently needed.

COVID-19 is highly infectious and transmission of the virus is thought to be similar tothat of influenza which can be transferred through droplets released when a personcoughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may bean important way to deliver treatments that could reduce the amount of a virus that ispresent in the nose and mouth. This also could mean that there is less virus available topass on to others. We want to see if the use of nose rinses and mouth washes usingPovidone-Iodine will reduce the the amount of virus in the nose and throat of people whohave tested positive for COVID-19 disease and also reduce the spread of infection withintheir household.

This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety andEfficacy of Imatinib for Hospitalized Adults with COVID-19

This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dosecombination formulation for subcutaneous injection (PH FDC SC) administered at home by ahome health nursing provider for patients with human epidermal growth factor receptor2-positive (HER2+) breast cancer who have completed concurrent chemotherapy withpertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV)and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDCSC, or trastuzumab SC in the clinic. The main objective is to enable continuity of careduring the COVID-19 pandemic.This study will enroll approximately 200 patients in the United States.Participants with early or metastatic HER2+ breast cancer will be enrolled in this study.Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks andcontinue treatment unless early cessation is necessary due to disease recurrence, diseaseprogression, unacceptable toxicity, participant withdrawal of consent, or per physician'srecommendation. Participants with early HER2+ breast cancer will receive PH FDC SC tocomplete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, ortrastuzumab SC they received prior to enrolling in this study, unless early cessation isnecessary due to disease recurrence, disease progression, unacceptable toxicity,participant withdrawal of consent, or per physician's recommendation.A remote cardiac surveillance substudy will be optional for patients enrolled at selectsites.The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer arisk for this patient population.

Investigational medications adjunct to clinical standard of care treatment will beassessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. Allhospitalized persons with moderate to severe COVID-19 disease that meet eligibilitycriteria will be offered participation.

The primary objective of this study is to provide expanded access of remdesivir (RDV) forthe treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.