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IRCT20190226042851N1 IRCT 2020-10-05 Ahvaz University of Medical Sciences Evaluation of the effect of nano-based inhalation solution to relieve shortness of breath in COVID-19 patients Evaluation of the effect of inhaled solution based on silver colloid with the brand name colloide silver nasal spray 10ppm to control COVID-19-induced lung infection and increase patients' respiratory volume 2020-08-22 anticipated 40 Complete https://irct.ir/trial/48462 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a supportive treatment that is implemented alongside the national protocol. In fact, the patient routinely receives the prescribed drug according to the approved protocol of the country and will receive the study drug as an additional or excess drug and has no interaction with the country's treatment protocol, Randomization description: First, patients with inclusion criteria are selected. They are then selected based on simple randomization using the lottery method. To do this, the patients' names are written on paper and placed in a box, then the papers are taken out one by one until the desired sample size is complete. 3 sars-covid-19 - covid-19. Intervention 1: Intervention group: In addition to receiving the drug according to the national protocol, this group uses the drug under study by inhalation. The national protocol uses interferon beta-1a, interferon beta-1b, dexamethasone, prednisolone, corticosteroids, and heparin.This drug consists of deionized water and nano-sized silver particles with the chemical formula Ag. The equipment used in this study is only a nebulizer mask. Drug prescription: 1cc will be prescribed to investigate possible side effects of the drug. The next dose will be administered to the patient 4 hours after the first dose in the amount of 2 cc and then for 72 hours and every 8 hours 3cc. The drug is placed in a nebulizer and given to the patient for 10-15 minutes. Intervention 2: Control group: This study does not have a placebo, so patients in this group do not receive any medication from the study and receive medication according to the national protocol. The national protocol uses the drugs interferon beta-1a, interferon beta-1b, dexamethasone, prednisolone, corticosteroids and heparin. In addition to the patient's SPO2, history and clinical examination are taken from the patient. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hakim abiavy
emam khomeini hospital, naderi
ahwaz Iran (Islamic Republic of) 6144947855 0613787287 hakim.abiavy76@gmail.com Ahvaz University of Medical Sciences scientific Yousefi farid
Ahvaz Jondishapour University of Medical Sciences
ahwaz Iran (Islamic Republic of) 6135715794 +98 61 3333 6513 drfayo@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Positive PCR test The patient is not COPD Not having acute kidney problems The patient does not have Acute liver failure 18 years and older The patient does not need ventilator therapy The patient has low respiratory capacity The patient has covide-19 18 years no limit Both The patient is hospitalized for less than seven days U07.1 COVID-19 Disease Treatment - Drugs N/A Intervention group: In addition to receiving the drug according to the national protocol, this group uses the drug under study by inhalation. The national protocol uses interferon beta-1a, interferon beta-1b, dexamethasone, prednisolone, corticosteroids, and heparin.This drug consists of deionized water and nano-sized silver particles with the chemical formula Ag. The equipment used in this study is only a nebulizer mask. Drug prescription: 1cc will be prescribed to investigate possible side effects of the drug. The next dose will be administered to the patient 4 hours after the first dose in the amount of 2 cc and then for 72 hours and every 8 hours 3cc. The drug is placed in a nebulizer and given to the patient for 10-15 minutes. Control group: This study does not have a placebo, so patients in this group do not receive any medication from the study and receive medication according to the national protocol. The national protocol uses the drugs interferon beta-1a, interferon beta-1b, dexamethasone, prednisolone, corticosteroids and heparin. In addition to the patient's SPO2, history and clinical examination are taken from the patient. The patient's respiratory capacity. Timepoint: Before reading And is monitored daily during the study. Method of measurement: Encouraging spirometry device - pulse oximeter - clinical examination. Control of the patient's pulmonary infection. Timepoint: Clinical examinations and measurements of the patient's body temperature are performed daily before the study and during the study - the patient's CT scan is taken before the start of the study and at the end of the study. Method of measurement: Clinical examinations - mercury thermometer - CT scan. Compelet blood count. Timepoint: The first and last day of the study are monitored. Method of measurement: Blood sampling from the patient. Alkaline Phosphatase. Timepoint: The first and last day of the study are monitored. Method of measurement: Blood sampling from the patient. Urine analysis. Timepoint: The first and last day of the study are monitored. Method of measurement: Urine sampling of the patient. Ahvaz University of Medical Sciences Approved 2020-06-20 Ahvaz Jundishapur University Ethics Committee shahre daneshgahi Town Ahwaz Khouzestan Iran (Islamic Republic of)