COVID-19 Clinical Trials and Expanded Access

A pilot study to investigate the effects of the prone positioning (PP) on hospitalpatients diagnosed with COVID-19 pneumonia.Investigators that early self-proning may prevent intubation and improve mortality inpatients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2).Up to 100 participants with a primary diagnosis of confirmed COVID-19 pneumonia will beenrolled to the study.All participants will be screened and those that meet inclusion and exclusion criteriawill be enrolled to one of two groups: one with prone positioning (on the belly) and theother with standard supine positioning (on the back). The patient and nursing staff willmonitor times spent in various positions.Outcome measures include incidence of intubation, max oxygen requirements, length ofhospital stay, ventilator-free days, worsening of oxygenation saturation, and mortality.

In this study we cross-reference several nationwide high-quality Swedish registers inorder to study risk factors for severe Covid-19 outcomes.

Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN®injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by thethymus gland. Ta1 is a biological response modifier which activates various cells of theimmune system, and is therefore expected to have clinical benefits in disorders whereimmune responses are impaired or ineffective, including acute and chronic viral andbacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stagerenal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease andfrequent burden of comorbidities, also have increased risk of exposure to communicablediseases as they are treated several times each week at hemodialysis centers with severalother patients and clinic staff in attendance. The majority of patients are over 60 yearsof age and many are receiving immunosuppressive medications. Accordingly, ESRD patientsare particularly susceptible to COVID-19 infection. Ta1 has been shown to be safelyadministered to hemodialysis patients. It is our hypothesis that a course of Ta1administered to individuals with ESRD will reduce the rate and severity of infection withCOVID-19.

This is an observational study. The aim is to describe the natural history and clinicalevolution over time of hospitalized patients affected by Severe Acute RespiratorySyndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of thedisease and improve therapeutic procedures.

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in thehuman race resulting in a world-spanning pandemic came as a surprise and at a tremendouscost both for individual human lives as well as for the society and the health caresector. The knowledge on how this new infection affects both the mother and the unbornchild as well as the outcomes for the mother and the child in the long run are unknown.What is known is based on case-reports and small case-series solely. Both thecoronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe AcuteRespiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring,which leads to the question whether this could be the case also for SARS-CoV-2.Aims: To establish a biobank of biological material from infected as well as non-infectedpregnant women and their offspring. To combine this biobank with Swedish quality andhealth care registers, computerized patient charts and questionnaire data, enabling bothshort-term follow up, such as obstetric outcomes, as well as long-term outcomes both formother and child. To study how the pandemic situation affects both the mother and herpartner in their experience of pregnancy, childbirth, and early parenthood.Design: A national Swedish multicentre study. Women are included when they have apositive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019(COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included attheir routine visits (Screening group). Blood samples and other biological material willbe collected at different time-points. Additional predictors and outcomes are collectedfrom the Swedish Pregnancy Register as well as obligatory Swedish health registers. Thebiobank and its linkage to health registers through the Swedish personal identificationnumber will enable future research. Child development will be followed during the firstyear of life by questionnaires to the parents. Womens' and their partners' experience ofchildbirth and parenthood will be studied in form of questionnaires as well as in form ofinterviews.Conclusion: This project will help obstetricians and neonatologists better recognizeclinical manifestations of the virus, identify possible risk factors during pregnancy andtailor therapies alongside providing right level of surveillance and management duringpregnancy, delivery, and child health care.

This phase III trial compares low dose whole lung radiation therapy to best supportivecare plus physicians choice in treating patients with COVID-19 infection. Low dose wholelung radiation therapy may work better than the current best supportive care andphysician's choice in improving patients' clinical status, the radiographic appearance oftheir lungs, or their laboratory blood tests.

The aim of this preliminary study is to describe the potential decline in forcedexpiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by homespirometry in high-risk subjects infected with COVID-19. We hypothesize that themagnitude of such a decline in FEV1 and/or FVC may be associated with clinicaldeterioration and hospitalization. The study will ultimately inform a larger subsequentRCT that will evaluate the efficacy of home spirometry in the early detection (prerespiratory symptoms) of respiratory complications and therefore prompt early medicalattention which is a key for improving outcome.

The purpose of this study is to find out if immunization with IMM-101 will reduce theincidence of severe respiratory and COVID-19 infections in cancer patients.

This is a multicenter prospective study that aims to investigate the clinical impact ofSARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

Until now there is no vaccine or reliable treatment for the COVID-19 pandemic. Thefundamental mechanisms of non-invasive low-level laser in photobiomodulation (PBM) andphotodynamic therapy is to stimulate the mitochondrial respiratory chain where atransient release of non-cytotoxic levels of reactive oxygen species (ROS) will lead topositive modulation of the immune response. As previous studies mentioned that the mostimportant strategy for COVID-19 management is oxygenation and faster rehabilitation ofthe damaged tissue, antiviral effects, and, finally, reduction or controlling the cytokinestorm by reducing inflammatory agents. PBM may be used as adjuvant therapy or even analternative therapy in all these mechanisms without side effects and drug interactions.Objectives The objective of this clinical trial is to use the photobiomodulation therapy(PBMT), and photodynamic therapy as adjuvant therapy or even an alternative therapy forCovide-19.Patients and methods A randomized controlled study will be conducted on 60 patients ofpositive COVID 19. The patients will be divided into 3 equal groups. Group, I willreceive a low-level laser (diode laser 980nm) from laser watch for 30 minutes, 20 J for 3to 5 days, and laser acupuncture. Group 2 will be treated with photodynamic therapy byinjecting the methylene blue as a photosensitizer and irradiated with laser watch (diodelaser 670 nm). Group 3 will serve as a control. Evaluation methods will includelaboratory investigations and CT chest.