Study: NCT04475588

Adverse event: Pericardial effusion due to underlying hypothyroidism
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated event in Arm A
Frequency: 1 affected / 22 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Related event in Arm A
Frequency: 1 affected / 22 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Patient had Infusion Reaction, did not complete initial dose. Event resolved same day. Per protocol, patient not completing first infusion were not evaluable \& were replaced. Patient recovered \& was discharged 2-wks later.
Frequency: 1 affected / 22 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 1 Pt. had chills did not complete initial dose. Event resolved same day. Per protocol pt. not completing 1 dose were not evaluable \& replaced. Pt had COVID19 complications, death 9 days later, deemed not related to drug. Stated in all cause mortality
Frequency: 5 affected / 22 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Fibrin D dimer increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 22 at risk

Adverse event: Non-high-density lipoprotein cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Outcome death, in Arm B
Frequency: 2 affected / 10 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Outcome was death, in Arm B
Frequency: 2 affected / 10 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk