Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: 1. signed informed consent for participation in this study. 2. hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus (covid-19). 3. moderate covid-19. moderate course of the disease is characterized by pneumonia on chest computed tomography (ct) (ct-1,2 stages) and body temperature \> 38 °c, in combination with 1 or more of the following: * spo2 \<95%, * respiratory rate \> 22, * dyspnea on exertion, * c-reactive protein (crp) level\> 10 mg / l, * one of the following risk factors: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years. 4. the presence of signs of hyperinflammation. signs of hyperinflammation are body temperature ≥ 38 °c for 2 days or more, combined with 1 or more of the following: * crp level \> 3 upper normal limit (unl), * white blood cell count - 2.0-3.5 × 10\^9 / l, * absolute lymphocyte count - 1.0-1.5 × 10\^9 / l 5. infection caused by the sars-cov-2 confirmed by of polymerase chain reaction (pcr) test or an express test for antigen / antibodies to sars-cov-2 framework of the protocol. 6. ability to follow protocol requirements and perform all clinical trial procedures. 7. the willingness of the participants and their sexual partners to use reliable methods of contraception, during the entire study and at least 3 months after the treatment completion. this requirement does not apply to participants who have undergone surgical sterilization as well as to women with permanent cessation of menstruation, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status (eg, appropriate age). reliable methods of contraception involve the use of one barrier method in combination with one of the following: spermicides, intrauterine spiral/oral contraceptives in a sexual partner. 8. willingness not to drink alcohol during the entire study. additional inclusion criteria for the pharmacokinetics (pk) subgroup: 1. signed informed consent to participate in the additional study of pharmacokinetics. 2. body mass index 18.5 - 35.0 kg/m2. 3. the ability of the patient, by the opinion of the investigator, to participate in the additional study of pharmacokinetics and to provide the required number of blood samples.

inclusion criteria: 1. signed informed consent for participation in this study. 2. hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus (covid-19). 3. moderate covid-19. moderate course of the disease is characterized by pneumonia on chest computed tomography (ct) (ct-1,2 stages) and body temperature \> 38 °c, in combination with 1 or more of the following: * spo2 \<95%, * respiratory rate \> 22, * dyspnea on exertion, * c-reactive protein (crp) level\> 10 mg / l, * one of the following risk factors: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years. 4. the presence of signs of hyperinflammation. signs of hyperinflammation are body temperature ≥ 38 °c for 2 days or more, combined with 1 or more of the following: * crp level \> 3 upper normal limit (unl), * white blood cell count - 2.0-3.5 × 10\^9 / l, * absolute lymphocyte count - 1.0-1.5 × 10\^9 / l 5. infection caused by the sars-cov-2 confirmed by of polymerase chain reaction (pcr) test or an express test for antigen / antibodies to sars-cov-2 framework of the protocol. 6. ability to follow protocol requirements and perform all clinical trial procedures. 7. the willingness of the participants and their sexual partners to use reliable methods of contraception, during the entire study and at least 3 months after the treatment completion. this requirement does not apply to participants who have undergone surgical sterilization as well as to women with permanent cessation of menstruation, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status (eg, appropriate age). reliable methods of contraception involve the use of one barrier method in combination with one of the following: spermicides, intrauterine spiral/oral contraceptives in a sexual partner. 8. willingness not to drink alcohol during the entire study. additional inclusion criteria for the pharmacokinetics (pk) subgroup: 1. signed informed consent to participate in the additional study of pharmacokinetics. 2. body mass index 18.5 - 35.0 kg/m2. 3. the ability of the patient, by the opinion of the investigator, to participate in the additional study of pharmacokinetics and to provide the required number of blood samples.

Feb. 14, 2023, noon usa

inclusion criteria: signed informed consent for participation in this study. hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus (covid-19). moderate covid-19. moderate course of the disease is characterized by pneumonia on chest computed tomography (ct) (ct-1,2 stages) and body temperature > 38 °c, in combination with 1 or more of the following: spo2 <95%, respiratory rate > 22, dyspnea on exertion, c-reactive protein (crp) level> 10 mg / l, one of the following risk factors: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years. the presence of signs of hyperinflammation. signs of hyperinflammation are body temperature ≥ 38 °c for 2 days or more, combined with 1 or more of the following: crp level > 3 upper normal limit (unl), white blood cell count - 2.0-3.5 × 10^9 / l, absolute lymphocyte count - 1.0-1.5 × 10^9 / l infection caused by the sars-cov-2 confirmed by of polymerase chain reaction (pcr) test or an express test for antigen / antibodies to sars-cov-2 framework of the protocol. ability to follow protocol requirements and perform all clinical trial procedures. the willingness of the participants and their sexual partners to use reliable methods of contraception, during the entire study and at least 3 months after the treatment completion. this requirement does not apply to participants who have undergone surgical sterilization as well as to women with permanent cessation of menstruation, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status (eg, appropriate age). reliable methods of contraception involve the use of one barrier method in combination with one of the following: spermicides, intrauterine spiral/oral contraceptives in a sexual partner. willingness not to drink alcohol during the entire study. additional inclusion criteria for the pharmacokinetics (pk) subgroup: signed informed consent to participate in the additional study of pharmacokinetics. body mass index 18.5 - 35.0 kg/m2. the ability of the patient, by the opinion of the investigator, to participate in the additional study of pharmacokinetics and to provide the required number of blood samples.

inclusion criteria: signed informed consent for participation in this study. hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus (covid-19). moderate covid-19. moderate course of the disease is characterized by pneumonia on chest computed tomography (ct) (ct-1,2 stages) and body temperature > 38 °c, in combination with 1 or more of the following: spo2 <95%, respiratory rate > 22, dyspnea on exertion, c-reactive protein (crp) level> 10 mg / l, one of the following risk factors: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years. the presence of signs of hyperinflammation. signs of hyperinflammation are body temperature ≥ 38 °c for 2 days or more, combined with 1 or more of the following: crp level > 3 upper normal limit (unl), white blood cell count - 2.0-3.5 × 10^9 / l, absolute lymphocyte count - 1.0-1.5 × 10^9 / l infection caused by the sars-cov-2 confirmed by of polymerase chain reaction (pcr) test or an express test for antigen / antibodies to sars-cov-2 framework of the protocol. ability to follow protocol requirements and perform all clinical trial procedures. the willingness of the participants and their sexual partners to use reliable methods of contraception, during the entire study and at least 3 months after the treatment completion. this requirement does not apply to participants who have undergone surgical sterilization as well as to women with permanent cessation of menstruation, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status (eg, appropriate age). reliable methods of contraception involve the use of one barrier method in combination with one of the following: spermicides, intrauterine spiral/oral contraceptives in a sexual partner. willingness not to drink alcohol during the entire study. additional inclusion criteria for the pharmacokinetics (pk) subgroup: signed informed consent to participate in the additional study of pharmacokinetics. body mass index 18.5 - 35.0 kg/m2. the ability of the patient, by the opinion of the investigator, to participate in the additional study of pharmacokinetics and to provide the required number of blood samples.

Jan. 14, 2022, 10 a.m. usa

inclusion criteria: signed informed consent for participation in this study. hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus (covid-19). moderate covid-19. moderate course of the disease is characterized by pneumonia on chest computed tomography (ct) (ct-1,2 stages) and body temperature > 38 °c, in combination with 1 or more of the following: spo2 <95%, respiratory rate > 22, dyspnea on exertion, c-reactive protein (crp) level> 10 mg / l, one of the following risk factors: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years. the presence of signs of hyperinflammation. signs of hyperinflammation are body temperature ≥ 38 °c for 2 days or more, combined with 1 or more of the following: crp level > 3 upper normal limit (unl), white blood cell count - 2.0-3.5 × 10^9 / l, absolute lymphocyte count - 1.0-1.5 × 10^9 / l infection caused by the sars-cov-2 confirmed by of polymerase chain reaction (pcr) test or an express test for antigen / antibodies to sars-cov-2 framework of the protocol). ability to follow protocol requirements and perform all clinical trial procedures. the willingness of the participants and their sexual partners to use reliable methods of contraception, during the entire study and at least 3 months after the treatment completion. this requirement does not apply to participants who have undergone surgical sterilization as well as to women with permanent cessation of menstruation, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status (eg, appropriate age). reliable methods of contraception involve the use of one barrier method in combination with one of the following: spermicides, intrauterine spiral/oral contraceptives in a sexual partner. willingness not to drink alcohol during the entire study. additional inclusion criteria for the pharmacokinetics (pk) subgroup: signed informed consent to participate in the additional study of pharmacokinetics. body mass index 18.5 - 35.0 kg/m2. the ability of the patient, by the opinion of the investigator, to participate in the additional study of pharmacokinetics and to provide the required number of blood samples.

inclusion criteria: signed informed consent for participation in this study. hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus (covid-19). moderate covid-19. moderate course of the disease is characterized by pneumonia on chest computed tomography (ct) (ct-1,2 stages) and body temperature > 38 °c, in combination with 1 or more of the following: spo2 <95%, respiratory rate > 22, dyspnea on exertion, c-reactive protein (crp) level> 10 mg / l, one of the following risk factors: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years. the presence of signs of hyperinflammation. signs of hyperinflammation are body temperature ≥ 38 °c for 2 days or more, combined with 1 or more of the following: crp level > 3 upper normal limit (unl), white blood cell count - 2.0-3.5 × 10^9 / l, absolute lymphocyte count - 1.0-1.5 × 10^9 / l infection caused by the sars-cov-2 confirmed by of polymerase chain reaction (pcr) test or an express test for antigen / antibodies to sars-cov-2 framework of the protocol). ability to follow protocol requirements and perform all clinical trial procedures. the willingness of the participants and their sexual partners to use reliable methods of contraception, during the entire study and at least 3 months after the treatment completion. this requirement does not apply to participants who have undergone surgical sterilization as well as to women with permanent cessation of menstruation, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status (eg, appropriate age). reliable methods of contraception involve the use of one barrier method in combination with one of the following: spermicides, intrauterine spiral/oral contraceptives in a sexual partner. willingness not to drink alcohol during the entire study. additional inclusion criteria for the pharmacokinetics (pk) subgroup: signed informed consent to participate in the additional study of pharmacokinetics. body mass index 18.5 - 35.0 kg/m2. the ability of the patient, by the opinion of the investigator, to participate in the additional study of pharmacokinetics and to provide the required number of blood samples.