Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Male and non-pregnant female patients more than or equal to 18 years of age will be eligible if they meet all of the following criteria: <br/ >1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. <br/ >2. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. <br/ >3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening. <br/ >4. Have an oxygen saturation of >94% while breathing ambient air. <br/ >5. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. <br/ >6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.

Male and non-pregnant female patients more than or equal to 18 years of age will be eligible if they meet all of the following criteria: <br/ >1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. <br/ >2. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. <br/ >3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening. <br/ >4. Have an oxygen saturation of >94% while breathing ambient air. <br/ >5. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. <br/ >6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.

Nov. 13, 2021, 5:33 p.m. oms

Feb. 27, 2021, 12:45 a.m. oms

Male and non-pregnant female patients more than or equal to 18 years of age will be eligible if they meet all of the following criteria: <br/ >1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. <br/ >2. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. <br/ >3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening. <br/ >4. Have an oxygen saturation of >94% while breathing ambient air. <br/ >5. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. <br/ >6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.

Male and non-pregnant female patients more than or equal to 18 years of age will be eligible if they meet all of the following criteria: <br/ >1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. <br/ >2. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. <br/ >3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening. <br/ >4. Have an oxygen saturation of >94% while breathing ambient air. <br/ >5. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. <br/ >6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.